Ludwig Huber's Presentations on Validation and Compliance

This site lists presentations developed and delivered by Dr. Ludwig Huber.

Other training material from Ludwig Huber

 

• May 11 , 2010, Heidelberg, Germany
  APV Seminar: Network Infrastructure Qualification (in German)
  Risk Assessment for Networks
  
• March 31, 2010
  Qualification and Calibration of Stability Chambers
  Learn how to select, conduct and document the right test parameters and conditions
  
• March 25, 2010
  Documentation for FDA and ISO 17025 Compliance
  Step-by-step Instructions with Sample Documents
  
• March 23, 2010, Dublin, Ireland
  IVT Conference - European Validation Week
  90 min Interactive Discussion Session  
  Implementing New USP Chapters for Analytical Method Validation
  
• March 23, 2010, Dublin, Ireland
  IVT Conference - European Validation Week
  90 min Interactive Discussion Session  
  Equipment Qualification – Determine and Demonstrate “Fit for Intended Use”
  
• March 22, 2010, Dublin, Ireland
  IVT Conference - European Validation Week
  Plenary Lecture 
  How Much Validation is Enough
  
• March 8, 2010, Heidelberg, Germany
  Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
  Ludwig Huber: three presentations/Case StudyWorkshop
  1) FDA compliant RAW Data and other records
  2) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
  3) Workshop: How to demonstrate data integrity for raw data
  
• March 4, 2010
  How to Efficiently Get ISO 17025 Accreditation
  Step-by-step from the idea to cost-effective implementation
  
• March 3, 2010
  Analysis of Metal Impurities According to New USP Chapters
  Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities
  
• February 25, 2010
  Simplify Validation and Qualification with ASTM E2500
  Cost Effective Alternative for Equipment Qualification and System Validation
  
• February 18, 2010
  Validation and Use of Excel® Spreadsheets in Regulated Environments
  Comply with GxPs, Part11, HIPAA, SOX and other regulations.
  
• February 4, 2010
  Validation of Analytical Methods and Procedures
  Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
  
• Jan 29/30, 2008, Heidelberg, Germany (in German)
  Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
  Ludwig Huber: two presentations
  Validation and Qualification of Computer Systems
  Analytical Equipment Qualification
  
• January 21, 2010
  Stability Testing in Pharmaceutical and API Industry
  Learn how to design, conduct and document studies for FDA and ICH
  
• January 14, 2010
  Computer System Validation: Step-by-Step
  With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
  
• December 10, 2009
  FDA Compliant Transfer of Analytical Methods
  Prepare your Lab for the NEW USP General Chapter
  
• December 3, 2009
  FDA's New Enforcement of 21 CFR Part 11
  Strategies and Tools to implement FDA's New E-records&Signatures Directions
  
• November 17, 2009
  How to Efficiently Build a GLP Laboratory
  Step-by-step from design to cost-effective implementation
  
• November 5, 2009
  FDA Compliant HPLC Qualification and Performance Testing
  Learn how to select, conduct and document the right tests in the right sequence
  
• October 23, 2009
  Handling Out-of-specification Situations and Faiure Invrestigations
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• October 8, 2009
  Agilent Lab Informatics Conference
  Plenary Lecture: Cost Effective Software and Computer System Validation
  
  
• September 30, 2009
  Plenary Lecture: Analytca Hyderbad (Anacon India)
  Quality Assurance and Compliance in Laboratories
  
  
• September 25 and 30, 2009
  Agilent VIP Meeting, Bangalore/Hyderabad, India
  Plenary Lecture: Crafting an efficient & cost-effective Lab Compliance Program
  
  
• September 22/24, 2009 ,
  Hyderabad, Ahmedabad, Mumbai: India
  USP/Agilent Compliance Seminar Series
  Ludwig Huber - 2 Workshops New and Updated USP Chapters
  - Analyical Instrument Qualification (USP 1058)
  - Validation of Analytical Methods and Procedures (USP 621/1226)
  
• September 17, 2009
  Calibration and Qualification in Analytical Laboratories
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• September 5/6, 2009
  2 day workshop, Peking University, Beijing, China
  Practical Validation of Computer Systems in Analytical Laboratories
  
• September 3/4, 2009
  2 day workshop, Peking University, Beijing, China
  Analytical Instrument Qualification and Calibration
  
• July 30, 2009
  Six Steps to Successful FDA Inspections
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• July 23, 2009
  Understanding and Implementing ISO 17025
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• July 9, 2009
  Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
  Comply with the FDA and international guidances
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
•  June 18, 2009
  Latest Updates on Software and Computer System Compliance
  Learn from most recent conferences
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• June 10-12, 2009 ,
  Korea Seoul
  Agilent VIP Compliance Seminars
  Update on Worldwide Regulatory Compliance Initiatives
  Ludwig Huber
  4 Plenary Lectures
  - Workflow of the analytical process and compliance overview
  - Traceability and Measurement Uncertainty in Chemical Analysis
  - Management and Validation of Computers for ISO 17025
  - Requirement Management for Equipment and Computer Systems
  
• June 9, 2009 ,
  Korea Seoul
  Agilent Public Compliance Seminar
  Ludwig Huber - 6 Plenary Lectures
  - FDA’s New Globalization Act : Initiatives for more frequent foreign inspections -
    Impact on Pharmaceutical Companies and API manufacturers in Korea
  - Impact of ISO 17025 on Pharma and non-Pharma Testing Laboratories
  - Regulatory Requirements for Computer Systems
  - Understanding and Implementing the New EU Annex 11:
    Comparison to FDA 21 CFR Part 1
  - Validation of Chromatographic Data Systems in Practice
  - Managing Analytical Raw Data in Regulated Environments
  
• June 8, 2009 ,
  Korea Seoul
  Agilent Compliance Seminar for KFDA
  Ludwig Huber - 4 Plenary Lectures
  - Update on WW Regulatory Compliance Initiatives for Pharma and
    non-Pharma
  - FDA’s New Globalization Act
  - The New EU Annex 11 on Using Computers in GMP Environments
  - Impact of ISO 17025 on Pharma and non-Pharma Testing Laboratories
  
• June 4 and 5, 2009 ,
  Suzhou, Tianjin: China
  Agilent Compliance Seminar Series
  Ludwig Huber - 3 Plenary Lectures
  - The FDA Globalization Act of 2009
  - The New EU Annex 11 on Using Computers in GMP Environments
  - Update on USP Chapter <621>
  
• June 2, 2009, Singapore
  ISPE Interphex
  Plenary Lecture -  
  Understanding and Implementing the New EU Annex 11
  
• May 28, 2009
  Risk Based Computer System Validation and Part 11 Compliance
  With Strategies for FDA/EU Compliance and Practical Tools for Effective implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• May 20, 2009, Washington. USA
  IVT Conference - Computer System Validation
  90 min Interactive Discussion Session  
  Understanding and Implementing FDA Audit Trail Requirements
  
• May 19, 2009, Washington. USA
  IVT Conference - Computer System Validation
  90 min Interactive Discussion Session  
  Implementing New Guidelines for Validation of Laboratory Data Systems
  
• May 18, 2009, Washington. USA
  IVT Conference - Computer System Validation
  Plenary Lecture -  
  Understanding and Implementing the New EU Annex 11
  
• May 14, 2009
  Effective Verification of Compendial Methods
  Understanding USP and FDA Requirements and get Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• April 30, 2009
  Traceability in Chemical Analysis
  With strategies and tools for ISO 17025 and FDA Compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• April 23, 2009
  IT Infrastructure and Network Qualification
  Introduction and Strategies for Compliance and System Uptime
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• April 21/22, Mannheim, Germany
  Concept-Heidelberg Conference: Pharma Lab Manager Conference (in German)
  Ludwig Huber: Plenary Lecture
  Practical Impact of USP <1058>, GAMP 5 and the New Annex 11 on Laboratories
  
• April 8, 2009
  Management and Validation of Computers for ISO 17025
  Requirements, Recommendations and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• March 25-April 2, 2009 ,
  Mexico City - San Juan - Rio de Janeiro - Sao Paulo - Buenos Aires
  Agilent Compliance Seminar Series
  Ludwig Huber - 4 Plenary Lectures
  - Regulatory Requirements for Computer Systems
  - Validation of Chromatographic Data Systems in Practice
  - Managing Analytical Raw Data in Regulated Environments
  - Successful FDA Inspection
  
• March 20, 2009
  Understanding and Implementing ISO 17025
  One day workshop
  Analytica Vietnam, Hanoi
  
• March 17, 2009
  Compliance in Pharmaceutical Laboratories
  Discussion Forum
  Institute for Drug Quality Control (IDQC), Hoh Chi Minh City, Vietnam
  
• March 13, 2009
  Half Day Seminar and Discussion Forum: 3 topics
  Traceability in Laboratories for FDA and ISO17025 Compliance
  Cost Effective Management of Analytical Equipment
  Auditing Laboratories for FDA and ISO 17025 Compliance
  Ministry of Public Health
  
• March 5, 2009
  Measurement Uncertainty in Chemical Analysis
  With tools to comply with ISO17025 Standard and FDA expectations
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• February 12, 2009
  Validation and Use of Excel® Spreadsheets in Regulated Environments
  Comply with GxPs, Part11, HIPAA, SOX and other regulations.
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• February 5, 2009
  Requirement Management for Equipment and Computer Systems
  Strategies for Development, Documentation and Updating Requirement Specifications
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• Jan 29/30, 2008, Heidelberg, Germany (in German)
  Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
  Ludwig Huber: two presentations
  Validation and Qualification of Computer Systems
  Analytical Equipment Qualification
  
• Jan 21/22, San Juan, Puerto Rico, USA
  Validation and Part 11 Compliance for (Bio)pharmaceutical and Device Industry
  Two day workshop with Dr. Ludwig Huber
  
• January 9, 2009
  Master Planning for Software and Computer Validation
  With examples for master plan and several project plans
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  

Presentations in 2008

• Dec 11, 2008
  Auditing Computer Systems for FDA and EU Compliance
  For Validation and Part 11 Compliance in Pharmaceutical and Device Industries
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• Dec 4, 2008
  Effective Gap Analysis for ISO 17025
  With Practical Tools for Easy Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
• Nov 13, 2008
  Raw Data in FDA Regulated Environments
  FDA/EU compliant recording, maintenance and archiving
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Nov 06, 2008
  Bioanalytical Method Validation  (208)
  Conduct and Document for Efficiency and FDA and EMEA compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Oct 23, 2008
  Validation of Existing/Legacy Systems (207)
  Regulatory requirements and tools for implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Oct 16, 2008
  Residual Solvent Analysis According to USP <467> (206)
  Understanding and implementing the revised chapter
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• September 27, Shanghai, China
  Compliance Workflow in Laboratories  
  Comply with FDA and other regulations from sampling to archiving of results
  2 hours Workshop at the Agilent VIP 
  
  
• September 24/25, Shanghai, China
  2 Day Workshop at Analytica, China
  Ludwig Huber - Validation in Analytical Laboratories for FDA Compliance
  Day 1: Validation and Compliance Overview
  Day 2: Validation of Analytical Instruments and Computer systems
  
  
• September 24, Shanghai, China
  Analytica, China - Plenary Lecture
  Ludwig Huber - Analytical Instrument Qualification According USP <1058>
  Introduction, Update and Strategies for Implementation
  
  
• Sep 18, 2008
  Test Scripts and Protocols for Equipment and Computer Validation (205)
  With SOPs , examples scripts and protocols for FDA and EMEA compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Sept 4, 2008
  Effective Training Practices for FDA Compliance (204)
  What to train - How much to Train - How to Document Effectiveness
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 31, 2008
  FDA Globalization Act of 2008: More Fees, More Inspections (203)
  Understanding the impact on domestic and international companies
  Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 24, 2008
  Cost Effective Software and Computer System Validation (202)
  Take Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 16, 2008
  Why do We Have Regulations in Phama
  What are benefits for industry? How vendors support with regulation/compliance
  Ludwig Huber, Dinner Speech
  The Agilent Pharmaceutical Executive Dinner Party, Bangkok, Thailand
  
  
• July 14 and July 16, BKK  and Hoh Chi Min City - Vietnam
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Method Validation Requirements from the USP and FDA
  Impact on Pharmaceutical Analysis
  
  
• July 11, 2008, Mumbai - India
  Agilent VIP Dinner with Keynote Presentation
  Ludwig Huber - Keynote presentation
  FDA Globalization Act of 2008
  New fees, more inspections, more documentation
  
  
• July 7-10, 2008, Bangalore, Hyderabad, Ahmadabad, Mumbai - India
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Method Validation Requirements from the USP and FDA
  Impact on Pharmaceutical Analysis
  
• July 2, 2008
  FDA/EU cGMP Compliance for Laboratories (200)
  Requirements and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 26, 2008
  Writing Effective SOPs For Regulatory Compliance (198)
  Content, format, approval, training and distribution
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 20 and June 22, 2008, Osaka, Tokyo, Japan,
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Analytical Instrument Qualification (USP <1058>)
  Implementing the Final Release
  
  
• June 20 and June 22, 2008, Osaka, Tokyo, Japan,
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Impact of GAMP® 5 on Validation of Laboratory Computer Systems
  
  
• June 11, 2008
  Contingency and Disaster Recovery Planning for Computer Systems (197)
  To Ensure Business Continuity and Compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 29, 2008
  Development and Validation of Stability Indicating Methods (196)
  General Chapters, General Notices, Monographs, Forum, Reference Standards
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 20, 2008
  Sampling and Sample Handling in Laboratories (195)
  Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 12--14, 2008, New Jersey. USA
  I3 Day Workshop it
  All Workshops delivered Ludwig Huber 
  FDA Compliant Configuration Management and Change Control for Computer Systems
  Changes of Hardware, Firmware, Software, Networks, Documentation
  
  
• May 8, 2008
  Understanding and Implementing the New EU Annex 11 (199)
  Learn about specific requirements and get tools for implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 1, 2008, Baltimore. USA
  IVT Conference - Computer System Validation
  Plenary Lecture -  
  FDA Compliant Configuration Management and Change Control for Computer Systems
  Changes of Hardware, Firmware, Software, Networks, Documentation
  
  
• April 30, 2008, Baltimore. USA
  IVT Conference - Computer System Validation
  Plenary Lecture -  
  Learning from Recent FDA Warning Letters Related to Computer System Validation and Part 11
  With Clear Recommendations for Corrective and Preventive Actions
  
  
• April 29, 2008, Baltimore. USA
  IVT Conference - Laboratory Controls and Compliance
  Plenary Lecture -  
  System Suitability Testing in Compendial Chromatographic Methods
  Understanding and Implementing Recent Changes of USP and EP
  
  
• April 29 - May 2, 2008, Baltimore. USA
  IVT Conference - Laboratory Controls and Compliance
  Ludwig Huber - 90 min Interactive Session
  Understanding and Implementing Analytical Instrument Qualification According to USP
   
  
• April 15, 2008
  Selection and Use of (Certified) Reference Material (194)
  Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
  Learn from your desk or in your seminar room
  
  
• April 3, 2008
  Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 (193)
  With Clear Recommendations for Corrective and Preventive Actions
  Learn from your desk or in your seminar room
  
  
• March 27, 2008
  Understanding the New USP <1058> for Analytical Instrument Qualification (192)
  Strategies for  FDA and ISO 17025 Compliance and Tools for Implementation
  Learn from your desk or in your seminar room
  
  
• March 13, 2008
  Understanding USP Documents and Reference Standards (191)
  General Chapters, General Notices, Monographs, Forum, Reference Standards
  Learn from your desk or in your seminar room
  
  
• February 28, 2008
  Validation of Analytical Methods and Procedures (190)
  Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• February 14, 2008
  Understanding and Implementing ISO 17025
  Requirements, Strategies and and Tool Kits for Laboratory Accreditation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• February 7, 2008, 2007
  Validation and Use of Excel® Spreadsheets in Regulated Environments
  Comply with GxPs, Part11, HIPAA, SOX and other regulations.
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• January 30, 2008, 2007
  FDA Requirements for Marketing Pharmaceutical Products in the United States
  Presentation and Round Table Discussion, Stuttgart, Germany
  
  
• Jan 29/30, 2008, Heidelberg, Germany (in German)
  Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
  Ludwig Huber: two presentations
  Validation and Qualification of Computer Systems
  Analytical Equipment Qualification
  
  
• January 10, 2008, 2007
  System Suitability in Chromatographic Compendial Methods
  Understanding and Implementing Recent Changes of USP and EP
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room

Presentations in 2007

• December 6, 2007
  Laboratory Failure Investigations, OOS and CAPA
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Dec 1/2, 2007, Beijing, China
  Ludwig Huber - 2 Day Workshop
  Equipment Qualification and Computer System Validation in Analytical Laboratories
  - Day 1: Calibration and Qualification of Equipment
  - Day 2: Practical Computer System Validation and Part 11 Compliance
   
  
• Nov 13, 2007, Tokyo, Japan
  Annual Japan PDA Conference
  Ludwig Huber - Plenary lecture
  Implementation of Electronic Records and Signatures in Europe
  
  
• Nov 12, 2007, Tokyo, Japan
  Japan PDA ERES Task Force Meeting
  Ludwig Huber - Plenary lecture and interactive discussion
  FDA Update on Electronic Records - Regulation, Guidance, Enforcement
  
  
• November 8, 2007
  Cost Effective Electronic Archiving for FDA Compliance Recorded - CD Available
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Nov 2, 2007, Hyderabad, India
  Seminar at Dr. Reddys
  Ludwig Huber - Interactive Discussion
  Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing
  
  
• Nov 2, 2007, Hyderabad, India
  Seminar at Matrix
  Ludwig Huber - Interactive Discussion
  Practical Computer System Validation and Part11 Compliance
  
  
• Nov 1, 2007, Hyderabad, India
  Anakon
  Ludwig Huber - Plenary Lecture
  Implementing USP <1058> for Analytical Instrument Qualification
  
  
• Oct 30, 2007, Amman, Jordan
  USP Conference
  Ludwig Huber - Verification of Compendial Procedures
  FDA Compliance and Recommendations for Implementation
  
  
• October 25, 2007
  Validation of Chromatographic Data Systems Recorded - CD Available
  - With Validation Examples from Planning to System Retirement -
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• October 18, 2007
  Electronic Audit Trail for FDA Compliance Recorded - CD Available
  Requirements - Implementation - Validation - Documentation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Oct 23, 2007, Basel, Switzerland
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• Oct 2-5, 2007, San Diego, CA, USA
  IVT Conference -Laboratory Controls and Compliance
  Ludwig Huber - 3 hours workshop
  Rawdata in the Laboratory: Definition, Maintenance, Archiving
  
  
• Oct 2-5, 2007, San Diego, CA, USA
  IVT Conference - Laboratory Controls and Compliance
  Ludwig Huber - Plenary Lecture
  Applying Risk Management to the Verification of Standard Methods
  
  
• Oct 1-4, 2007, San Diego, CA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - 90 Min interactive discussion session
  Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing
  
  
• Oct 1-4, 2007, San Diego, CA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - Half day pre-conference workshop
  Using Computers in Clinical Trials
  
  
• Oct 1-4, 2007, San Diego, CA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - Plenary Lecture
  Strategies for Implementing the New Part 11
  
  
• Sept 27, 2007
  Documentation for FDA Compliance Recorded - CD Available
  Step-by-step Instructions with Sample Documents
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Sept 26, 2007, Berlin Germany
  Agilent Informatics Users Meeting
  Ludwig Huber - Workshop
  Electronic Raw Data - Definition, Generation, Processing, Archiving
  
  
• Sept 25, 2007, Berlin Germany
  Agilent Informatics Users Meeting
  Ludwig Huber - Plenary Lecture
  Implementing FDA's Part 11
  
  
• Sep 17-21, 2007, Tokyo and Osaka, Japan
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• Sep 15-17, 2007, Singapore, Kuala Lumpur (Malaysia)
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• Sept 5, 2007
  Using the Internet and Intranet in Regulated Environments
  Recorded - CD Available
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• August 9, 2007
  Good Laboratory Practice Regulations Recorded - CD Available
  Introduction and strategies for implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 26, 2007
  Transfer of Analytical Methods and Procedures
  FDA Requirements, Strategies and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 18, Singapore
  HP Asia Pacific Pharmaceutical View Forum
  Risk Based Computer Validation for Highest Efficiency and FDA Compliance
  Ludwig Huber - Plenary Lecture
  
  
• July 12, 2007
  Risk Based Computer Validation for Highest Efficiency and FDA Compliance CD Available
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 11, 2007
  Verification of Compendial Methods
  Understanding the New USP Chapter<1226>
  ComplianceOnline Web Seminar
  
  
• June 28, 2007
  Implementing FDA's 'New' 21 CFR Part 11 CD Available
  Strategies and 10 Case Studies from Manufacturing, Offices and Laboratories
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 25, 2007, Heidelberg, Germany
  2nd European GMP Conference
  Process Validation: The New Validation Approach
  From 3 batches to continuous validation
  Chairman of 3 half day workshop
  European Compliance Academy
  
  
• June 20, 2007
  Analytical Instrument Qualification (USP <1058>)
  Recommendations for Implementation
  Video Web Seminar with Ludwig Huber
  Learn from your desk or in your seminar room
  
  
• June 14, 2007
  Network and IT Infrastructure Qualification CD Available
  Introduction and Strategies for Compliance and System Uptime
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 6, 2007
  Using Computerized Systems in Clinical Trials CD Available
  Understanding FDA's New Approach Towards Computer Systems
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 31, 2007
  Using Electronic Raw Data in FDA Regulated Environments CD Available
  Effective writing, implementation, reviews and updates
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 14-18, 2007, 5 City Tour, India
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• May 10, 2007
  Verification of Compendial Methods CD Available
  Understanding the New USP Chapter<1226>
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 3, 2007
  Retirement of Computer Systems CD Available
  Strategies for FDA Compliance and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• April 24-26, 2007, Alexandria, VA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - 90 Min interactive discussion session
  Implementing the New 21 CFR Part 11 for Pharmaceutical Development and Manufacturing
  
  
• April 24-26, 2007, Alexandria, VA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - Plenary Lecture
  Electronic Raw Data – Definition, Recording, Maintenance, Archiving
  
  
• April 24-26, 2007, Alexandria, VA, USA
  IVT Conference - Computer System Validation
  Ludwig Huber - Plenary Lecture
  Strategies for Implementing the New Part 11
  
  
• April 19, 2007
  Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control CD Available
  Comply with the most recent FDA Guideline
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• April 5, 2007
  How to Comply with International GMP Regulations CD Available
  Prepare Your API&Pharmaceutical Manufacturing for FDA/EU/Japan/TGA/WHO Inspections
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• April 3/4, 2007, Istanbul, Turkey
  Academia Life Sciences Centre
  Ludwig Huber - Two day seminar
  Equipment Qualification and Computer Validation in Laboratories
  
  
• March 26-30, 2007, 5 City Tour, United States
  Agilent Compliance Seminar
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• March 22, 2007
  Computer System Validation for GLP CD Available
  How much is enough?
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• March 21, 2007, Delhi, India
  ComplianceOnline one day seminar
  Ludwig Huber: Computer System Validation and Part 11 Compliance in Practice
  *** Learn through case studies and examples ***
  
  March 15,, 2007, Athens, GA, USA
  31st International GMP Conference
  Ludwig Huber, 1/2 day Tutorial: Risk Based Equipment Qualification and System Validation in Testing Laboratories
  
  
• March 7/8,, 2007, Mannheim, Germany (in German)
  Concept-Heidelberg Seminar: Computer System Validation Conference(in German)
  Ludwig Huber: Long Term Archiving and Retrieval of Data
  
  
• March 1, 2007
  Learning From Laboratory Related FDA Warning Letters CD Available
  Learn from mistakes others made and how to avoid them
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Feb 15/16, 2007, Heidelberg, Germany
  APV Seminar: Network Infrastructure Qualification (in German)
  Ludwig Huber: Risk Assessment for Networks
  
  
• Feb 14, 2007
  FDA Compliant Standard Operating Procedures (165) CD Available
  Effective writing, implementation, reviews and updates
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• February 13, 2007
  Validation and Part 11 Compliance of Excel
  Compliance Online Webinar - From your desk
  
  
• Feb 8, 2007
  Configuration Management and Change Control of Computer Systems (164) CD Available
  Hardware - firmware - software - networks
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• Feb 7, 2007
  Risk Based Validation of Software and Computer Systems
  Optimize Your Resources and Comply with FDA Guidelines
  IVT Webseminar
  
  
• Jan 24/25, 2007, Mannheim, Germany
  Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
  Ludwig Huber: three presentations
  1) FDA compliant RAW Data and other records
  2) Validation of Electronic Records Systems
  3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control
  
  
• Jan 24/25, 2007, Heidelberg, Germany (in German)
  Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
  Ludwig Huber: two presentations
  Validation and Qualification of Computer Systems
  Analytical Equipment Qualification
  
  
• January 23, 2006
  Analytical Instrument Qualification According to USP Chapter <1058> (163) CD Available
  Introduction, Update and Recommendations for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• January 18, 2006
  Validation and Use of ExcelSpreadsheets in Regulated Environments (162) CD Available
  Requirements and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room

Presentations in 2006

 

• December 14, 2006
  Risk Management for Laboratory Systems (160) CD Available
  Requirements and Tools for Implementation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• December 5-7, 2006, Amsterdam, The Netherlands
  IVT Conference
  Computer System Validation
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• December 5-7, 2006, Amsterdam, The Netherlands
  IVT Conference
  Computer System Validation
  Ludwig Huber - Half day workshop
  Validation of Laboratory Data Systems
  
  
• December 5-7, 2006, Amsterdam, The Netherlands
  IVT Conference
  Equipment Qualification and System Validation
  Ludwig Huber - 90 minutes interactive discussion sessions
  Testing Laboratory Equipment for Operational Performance and Compliance
  
  
• December 5-7, 2006, Amsterdam, The Netherlands
  IVT Conference
  Equipment Qualification and System Validation
  Ludwig Huber - Plenary Lecture
  Qualification of Automated Systems
  
  
• December 1-3, 2006, Mumbai, India
  Indian Drug Pharmaceutical Conference
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• November 13-15, 2006, Tokyo, Japan
  PDA Asia Pacific Conference
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part11
  
  
• November 19-10, 2006, San Diego, United States
  Agilent Informatics Users Meetings
  Ludwig Huber - Plenary Lecture and Interactive Workshop
  Preparing Your Organization for the New Part11
  
  
• October 25, 2006, Boston, United States
  Agilent Compliance Seminar Series
  Ludwig Huber - Lecture
  Preparing Your Organization for the New Part11
  
  
• October 25, 2006, Boston, United States
  Agilent Compliance Seminar Series
  Ludwig Huber - Lecture
  Analytical Instrument Qualification - Implementing the New USP Draft <1058>
  
  
• November 7, 2006
  Managing Failure Investigations and OOS (161) CD Available
  Implementing the New FDA Guide
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• October 23, 2006
  Auditing Analytical Laboratories for FDA Compliance CD Available
  Preparation - conduct - follow up - documentation
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• October 19, 2006
  Raw Data in FDA/EU Regulated Environments CD Available
  Compliant recording, maintenance and archiving
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• October 3-5, 2006, Singapore
  IVT Validation and Compliance Summit
  Ludwig Huber - Half day workshop
  Risk Management for Laboratory Systems
  
  
• October 3-5, 2006, Singapore
  IVT Validation and Compliance Summit
  Ludwig Huber - 90 minutes interactive discussion session
  Analytical Instrument Qualification
  Implementing the new USP Chapter <1058> and the GAMP Laboratory GuideRaw Data in FDA/EU Regulated Environments
  Compliant recording, maintenance and archiving
  
  
• October 3-5, 2006, Singapore
  IVT Validation and Compliance Summit
  Ludwig Huber - 90 minutes interactive discussion session
  The Self Audit: Assessing the Lab for FDA Compliance
  
  
• October 3-5, 2006, Singapore
  IVT Validation and Compliance Summit
  Ludwig Huber - 90 minutes interactive discussion session
  Successful FDA Inspections – Preparation – Conduct – Follow up
  
  
• August 14-17, 2006, Airlington, USA
  IVT Conference: Computer System Validation
  Ludwig Huber - Plenary Lecture
  Preparing Your Organization for the New Part 11
  
  
• August 14-17, 2006, Airlington, USA
  IVT Conference: Computer System Validation
  Ludwig Huber - Plenary Lecture
  Implemeting International Regulations and Guidelines for Electonic Records&Signatures
  
  
• August 14-17, 2006, Alexadria, USA
  IVT Conference: Computer System Validation
  Ludwig Huber - Half Day workshop
  Validation of Laboratory Data Systems
  
  
• August 14-17, 2006, Alexadria, USA
  IVT Conference: Laboratory Regulations, Controls and Compliance
  Ludwig Huber - Plenary Lecture
  New Guidelines for Validation of Lab Equipment
  
  
• August 14-17, 2006, Alexadria, USA
  IVT Conference: Laboratory Regulations, Controls and Compliance
  Ludwig Huber - Half Day workshop
  Validation of Automated Equipment
  
  
• July 27, 2006
  Using the Intranet in Regulated Environments CD Available
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• July 13, 2006
  Increasing Productivity with Electronic Laboratory Notebooks CD Available
  Selection, Implementation and Strategies for Compliance
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 29, 2006
  Preparing Your Organization for the 'NEW' Part 11 (152) CD Available
  Learn What's Coming and How to Implement
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 22, 2006
  Using the SAFE Standard for Digital Signatures CD Available
  For legally enforceable IP Protection, Electronic Transactions and FDA Submissions
  Labcompliance Audio Seminar: Chairman Ludwig Huber
  Learn from your desk or in your seminar room
  
  
• June 8, 2006
  Effective GxP Training Practices CD Available
  Optimize Your Resources and Comply with FDA Guidelines
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• June 7, 2006
  Using Excel in Regulated Environments
  FDA Info - Expert Briefing - From your desk
  
  
• June 2, 2006, Prague
  The Fifth European Analytical Manager's Association Conference (EuroALMA)
  Plenary Lecture
  New Regulations and Guidelines for Analytical Laboratories
  
  
• May 31, 2006
  Risk Based Validation of Software and Computer Systems CD Available
  Optimize Your Resources and Comply with FDA Guidelines
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• May 30, 2006, Cologne
  PIC/S Inspector Meeting (Expert Circle)
  Presentation and discussion: Ludwig Huber
  Trends in QC Laboratories
  
  
• May 18, 2006
  Network Qualification CD Available
  Understanding the New GAMP/ISPE, IVT and FDA Guides
  Learn from your desk or in your seminar room
  
  
• May 17, 2006
  Change Control for Software and Computer Systems
  ComplianceOnline Webinar - From your desk
  
  
• May 4, 2006, Singapore
  One day Agilent seminar, three presentations
  * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
  * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualification
  * Introducing the New PIC/S Guide for Inspection of pharmaceutical Quality Control Laboratories .
  
  
  
• May 3, 2006, Bangkok, Thailand
  One day Agilent seminar, three presentations/workshops
  * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
  * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualificaction
  * The New PIC/S guide for Inspection of pharmaceutical Quality Control Laboratories .
  
  
  
• May 2, 2006, Kuala Lumpur, Malaysia
  One day Agilent seminar, three presentations/workshops
  * Electronic Raw Data in Regulated Environments - Definition, Maintenance, Archiving
  * Understanding the New GAMP and USP Guides for Laboratory Equipment Qualification
  * Introducing the New PIC/S Guide for Inspection of pharmaceutical Quality Control Laboratories .
  
  
  
• April 27, 2006 Jinan, China
  One day Agilent seminar, three presentations
  * Impact of FDA's Quality System Guide on Laboratories
  * Risk Based Validation and Part 11 Compliance for Laboratory Systems
  * System Based Inspections – Laboratory Control Systems.
  
  
  
• April 26, 2006, Beijing China
  Current Good Manufacturing Practices
  ISPE/US-FDA GMP Industry Training at University of Beijing
  Panel discussion: Joe Famulare, Erik Henrikson, Nick Buhay (US FDA, Office of Compliance) and Ludwig Huber (Labcompliance)
  
  
• April 25, 2006, Beijing China
  Lab Validation
  ISPE/US-FDA GMP Industry Training at University of Beijing
  Joint Workshop: Nick Buhay (US FDA) and Ludwig Huber (Labcompliance)
  
  
• April 20, 2006
  Developing a Validation Master Plan for Pharmaceutical Manufacturing CD Available
  Chairman: Ludwig Huber
  Presenter: Gabriela Bodea, Consultant
  Learn from your desk or in your seminar room
  
  
• April 18, 2006
  Validation and Use of MS Access Databases in GxP and Part11 Environments CD Available
  Chairman: Ludwig Huber
  Presenter: Tyson M. Mew, President of Ofni Systems Inc
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• April 11, 2006
  Documentation for GxP Compliance CD Available
  Requirements from US FDA, Europe, PIC/S, WHO
  Labcompliance Audio Seminar
  Learn from your desk or in your seminar room
  
  
• April 4-7, 2006, London, UK
  IVT Conference: Laboratory Controls and Compliance
  Ludwig Huber - Plenary Lecture
  Risk Management for Laboratory Systems
  
  
• April 4-7, 2006, London, UK
  IVT Conference: Laboratory Controls and Compliance
  Ludwig Huber - 90 min interactive discussion session
  Implementing the New GAMP Guide for Validation of Laboratory Computer Systems
  
  
• April 4-7, 2006, London, UK
  IVT Conference: Laboratory Controls and Compliance
  Ludwig Huber - 180 min workshop
  Implementing Analytical Instrument Qualification According to the New USP Draft <1058>
  
  
• April 4-7, 2006, London, UK
  IVT Conference: Laboratory Controls and Compliance
  Ludwig Huber - Plenary Lecture
  New Guidelines for Validation of Lab Equipment
  
  
• March 30, 2006
  Labcompliance Audio Seminar
  Validation of Analytical Methods and Procedures CD Available
  Learn from your desk or in your seminar room
  
  
• March 29, 2006
  Analytical Instrument Qualification
  Compliance Online Webinar - From your desk
  
  
• March 23, 2006
  Validation of Automated Laboratory Systems CD Available
  Learn from your desk or in your seminar room
  
  
• March 22, 2006
  Analytical Instrument Qualification
  ComplianceOnline Web seminar - From your desk
  
  
• March 14/17, 2006, Amsterdam, The Netherlands
  IVT Conference: Electronic Records Management
  Ludwig Huber - 90 minutes interactive session
  Managing 'Open Systems' for Compliance
  
  
• March 14/17, 2006, Amsterdam, The Netherlands
  IVT Conference: Electronic Records Management
  Ludwig Huber - Plenary lecture
  Managing Electronic Records&Signatures for Global Compliance
  
  
• March 14/17, 2006, Amsterdam, The Netherlands
  IVT Conference: Electronic Records Management
  Ludwig Huber - Half day workshop
  Implementing Risk Based Approaches for Electronic Records and Signatures
  
  
• March 8, 2006, Copenhagen, Denmark
  Using Excel in Regulated Environments
  Interactive discussion session: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records
  
  
• March 8, 2006, Copenhagen, Denmark
  Update on FDA Requirements for Laboratory Computers and Records
  Plenary lecture: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records
  
  
• March 8, 2006, Copenhagen, Denmark
  Implementing the New GAMP Guide on the Validation of Laboratory Computerized Systems
  Half day workshop at the: ECA conference: Recent FDA/EU Requirements for Laboratory Computers and Records
  
  
• March 7, 2006, Copenhagen, Denmark
  Qualification Requirements from Laboratory Systems to the IT Infrastructure
  Plenary lecture: ECA IT Infrastructure Conference
  
  
• March 6, 2006, Copenhagen, Denmark
  Qualification of Network Infrastructure
  Half Day Preconference Workshop at the ECA IT Infrastructure Conference
  
  
• March 2, 2006
  Labcompliance Audio Seminar
  Master Planning for Computer System Validation CD Available
  Learn from your desk or in your seminar room
  
  
• March 1, 2006
  Computer System Validation - Introduction and Strategies for Implementation
  IVT Tele seminar - From your desk
  
  
• February 22, 2006
  Validation and Part 11 Compliance of Excel
  Compliance Online Webinar - From your desk
  
  
• February 22, 2006
  Analytical Instrument Qualification
  IVT Tele seminar - From your desk
  
  
• February 14, 2006, Mannheim, Germany
  Validation of Laboratory Computer Systems (in German)
  Plenary Lecture at the ECA Computer Validation Conference: Agencies meet industry
  
  
• February 2, 2006
  Labcompliance Audio Seminar
  Change Control for Computer Systems CD Available
  Learn from your desk or in your seminar room
  
  
• Jan 25/26, 2006, Heidelberg, Germany (in German)
  Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
  Ludwig Huber: two presentations
  Validation and Qualification of Computer Systems (in German)
  
  
• January 19, 2006
  Labcompliance Audio Seminar
  FDA Compliant Testing for Validation and Qualification CD Available
  Learn from your desk or in your seminar room
  
  
• January, 2006
  Analytical Instrument Qualification
  IVT Tele seminar - From your desk

Presentations in 2005 and before

December 8, 2005
Labcompliance Audio Seminar
Validation of Configurable Off-the-shelf Computer Systems CD Available
Learn from your desk or in your seminar room

December 2, 2005, Hyderabad, India
Recent Developments in US-FDA and International GxP Regulations and Guidelines
Plenary Lecture at the Indian Pharmaceutical Congress 2005

November 30, Ahmedabad, India
One day Agilent seminar, three presentations
* Introduction and Update to Regulatory Requirements for cGMP and GCP
* Risk Based Approach to implementation of 21 CFR Part 11 in Pharmaceutical Laboratories
* An introduction to Instrument and Software Validation in the Pharma Lab:- How to avoid an FDA Warning Letter

November 17, 2005
Labcompliance Audio Seminar
FDA/EU Compliance in Analytical Laboratories CD Available
Learn from your desk or in your seminar room

November 16, 2005
Agilent Web Seminar
Electronic Rawdata in FDA Regulated Environments
Definition, maintenance, archiving, retrieval-
At your desk or in a seminar room

November 8, 2005, Baltimoore
Electronic Rawdata in FDA Regulated Environments
- Definition, maintenance, archiving, retrieval -
Agilent Informatics Users Meeting

November 3 2005
Labcompliance Audio Seminar
FDA Compliant Electronic Records Management CD Available
Learn from your desk or in your seminar room

October 28, 2005, Shijiaozhuang, China
Half Day Seminar
FDA Inspections of API Manufacturers
Key methods for optimal preparation, conducts, and follow-up
Agilent Compliance Seminar Series

October 26, 2005, Shanghai, China
Latest Updates on FDA's 21 CFR Part 11 - Electronic Records and Electronic Signatures
Plenary Lecture
ChinaPharm 2005 Conference

October 25, 2005, Shanghai, China
GMP and GLP Difference Between FDA/EU and China
Plenary Lecture
ChinaPharm 2005 Conference

October 20, 2005
Labcompliance Audio Seminar
Using Excel in Regulated Environments CD Available
Validation, Part 11 Compliance, Documentation
Learn from your desk or in your seminar room

October 7, 2005
Barnett Web Conference
Risk Based System Inspections
Key methods for optimal preparation, conducts, and follow-up
At your desk or in your seminar room

October 6, 2005
Labcompliance Audio Seminar
Strategies for an Effective Root Cause Analysis and CAPA Program CD Available
Gabriela Bodea presenting, Ludwig Huber moderating
Learn from your desk or in your seminar room

October 4, 2005
IVT Tele Seminar
Electronic Rawdata in FDA Regulated Environments
- Definition, maintenance, archiving, retrieval -
At your desk or in a seminar room

September 28 , 2005, Dublin, Ireland
Half Day Seminar
1) Electronic Rawdata in FDA Regulated Environments
Definition, maintenance, archiving, retrieval
2) Validation of Computerized Laboratory Systems
Implementing the new GAMP Laboratory Systems Guide
Agilent Compliance Seminar Series

September 26/28 , 2005, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - 90 minutes interactive discussion session
Using Excel Spreadsheets in FDA/EU Regulated Environment

September 26/28 , 2005, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
Validating Configurable Off-The-Shelf (COTS) Software

September 26/28 , 2005, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
User Requirement Specifications for Computer Systems

September 22, 2005
Labcompliance Audio Seminar
Analytical Instrument Qualification (AIQ) CD Available
Understanding the New USP Draft Guidance <1058>
Learn from your desk or in your seminar room

September 19 2005
Agilent Web Seminar
Risk Based Computer Validation and Part 11 Compliance
At your desk or in your seminar room

September 8, 2005
Labcompliance Audio Seminar
Managing Failure Investigations and OOS Situations CD Available
Regulatory Requirements and Strategies for Implementation
Learn from your desk or in your seminar room

September 7, 2005
Agilent Web Seminar
Validation of Computerized Laboratory Systems
Implementing the new GAMP Laboratory Systems Guide
At your desk or in a seminar room

Juli 27, 2005
Labcompliance Audio Seminar
Risk Management for FDA/EU Regulated Industries CD Available
Introduction and Strategies for Compliance and Troublefree Operations
Learn from your desk or in your seminar room

July 19-22, 2005, Philadelphia, PA
IVT Electronic Laboratory Notebooks Conference
Half min interactive session
FDA Requirements for Electronic Records and Signatures

July 19-22, 2005, Philadelphia, NJ
IVT Electronic Laboratory Notebooks Conference
Half-day workshop
Validation of Electronic Laboratory Notebooks for FDA Compliance

Juli 7, 2005
Labcompliance Audio Seminar
Validation of Computerized Laboratory Systems CD Available
Implementing the new GAMP Laboratory Systems Guide
Learn from your desk or in your seminar room

June 27-30, 2005, Dublin Ireland
European Validation Week
Plenary lecture
Global Validation Requirements

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
90 min Interactive Session
Conducting Risk-Based Validation of Software and Computer System

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
Plenary Lecture
Reducing Validation Costs through Risk Assessment

June 27-30, 2005, Dublin Ireland
Risk Assessment Conference
Half-day workshop
Risk Assessment in Analytical Laboratories

June 23, 2005
Labcompliance Audio Seminar
Electronic Rawdata in FDA Regulated Environments CD Available
Learn from your desk or in your seminar room

June 9, 2005
Labcompliance Audio Seminar
21 CFR Part 11: Electronic Records and Signatures CD Available
Introduction and Strategies for Cost-effective Compliance
Learn from your desk or in your seminar room

May 13, 2005
Labcompliance Audio Seminar
User Requirement Specifications for Software and Computer Systems CD Available
Strategies for Development, Documentation and Maintenance
Learn from your desk or in your seminar room

April 25-28, 2005, Washington DC
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - 90 minutes interactive discussion session
Using Excel Spreadsheets in FDA/EU Regulated Environment

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
Validating Configurable Off-The-Shelf (COTS) Software

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half Day Workshop
User Requirement Specifications for Computer Systems

April 25-28, 2005, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Plenary lecture:
The Top 10 Worst Computer Validation Mistakes to Commit

April 21, 2005
Labcompliance Audio Seminar
Network Infrastructure Qualification CD Available
Introduction and Strategies for Compliance and System Uptime
Learn from your desk or in your seminar room

April 19, 2005
Agilent Web Seminar
Pharmaceutical cGMPs for the 21st Century
At your desk or in a seminar room

April 16, 2005, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Plenary lecture:
Impact of FDA's Quality System Guide on Laboratories

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Half Day Workshop
Risk Based Validation and Part 11 Compliance for Laboratory Systems

April 11-14, Dublin, Ireland
IVT Conference: Laboratory Controls and Compliance
Ludwig Huber - Half Day Workshop
Configuration Management and Change Control for Laboratory Equipment and Computers

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - 90 minutes interactive discussion session
Handling OOS Results; Managing Deviations

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - Half Day Workshop
System Based Inspections – Quality Systems

April 4-7, Washington D.C., US
IVT Conference: FDA Inspections
Ludwig Huber - Half Day Workshop
System Based Inspections – Laboratory Control Systems

March 23, 2005
Labcompliance Audio Seminar
The Top 10 Worst Computer Validation Mistakes You can Make
Plus Strategies and Tools how to Avoid Them
Learn from your desk or in your seminar room

March 10, 2005
Labcompliance Audio Seminar
Managing Out of Specification Situations and Corrective/Preventive Actions CD Available
Learn from your desk or in your seminar room

February 21, 2005
Labcompliance Audio Seminar
How to Assess Suppliers of Software and Computer Systems CD Available
And reduce validation costs through supplier audits
Learn from your desk or in your seminar room

February 10, 2005
Labcompliance Audio Seminar
How to Comply with International GMP Regulations and Guidelines CD Available
Learn from your desk or in your seminar room

February 9, 2005
IVT Telseminar
Introduction to Computer Validation
Key Aspects of a Computer Validation Program –
Regulatory Expectations and Strategies for Implementation

Jan 27, 2005, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

January 19, 2005
Labcompliance Audio Seminar
Using Internet and Intranet in Regulated Environments CD Available
Learn from your desk or in your seminar room

January 5, 2005
Labcompliance Audio Seminar
Eight Steps for Successful Software and Computer Validation CD Available
Learn from your desk or in your seminar room

Presentations in 2004 and before

December 9, 2004
Labcompliance Audio Seminar
Validation and Use of Excel Spreadsheets in GxP and Part 11 Environments CD Available
Learn from your desk or in your seminar room

December 1, 2004, Shanghai, China
One day Agilent seminar, three presentations
* National and International GMP Regulations and Guidelines
* Validation and Compliance in Pharmaceutical Laboratories
* Inspection of Pharmaceutical Laboratories


November 24, 2004, Mumbai, India
Plenary lecture Anakon-Analytica 2004
* New FDA Directions for Part 11 Compliance and Computer Validation


November 23, 2004, Mumbai, India
One day Agilent seminar, three presentations
* New FDA Directions for Part 11 Compliance and Computer Validation
* FDA Inspection and Enforcement Practices for Analytical Equipment, Computer Systems and Networks
* Validation of Analytical Methods


November 17, 2004, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

November 9, Tokyo, Japan
Annual PDA Conference 2004
PDA Japan
Plenary lecture - Most Recent Updates for Part 11 and Recommendations for Implementation

November 3, 2004
Labcompliance Audio Seminar
Strategies to Implement FDA's New Quality System Guide CD Available
Learn from your desk or in your seminar room

October 26, 2004, Barcelona, Spain
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Plenary lecture - Compliance of Network Infrastructure and Systems

October 25, 2004, Barcelona, Spain
Update on FDA Requirements for Electronic records/signatures
European Compliance Academy
Plenary lecture - Update on FDA Requirements for Laboratory Computers

October 25, 2004, Barcelona, Spain
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Pre-conference Workshop - Validation and Part 11 Compliance for Laboratory Computers

October 19, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Half day workshop: Configuration Management and Change Control for Networks

October 19, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Plenary lecture: FDA Requirements for Networks

October 18, 2004, Philadelphia, PA, USA
IVT Conference: Network Qualification
Half day workshop: Introduction to 21 CFR Part 11 and FDA's New Approach

October 6, 2004
Labcompliance Audio Seminar
Audits of Computer Systems in Laboratories and Manufacturing CD Available
Learn from your desk or in your seminar room

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Plenary lecture:
Strategies to Define Part 11 Scope and Controls

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
90 min Interactive discussion session:
My Computer System is High, Medium or Low Risk. What does this mean?

Sep 26/29, 2004, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Half day Workshop: Change Control and Configuration Management for Computer Systems

September 23, 2004
Video Web Seminar
Strategies for Risk Based Laboratory System Validation

September 21, 2004
APV Seminar on IT Infrastructure Qualification
Risk Management for Networks

September 14, Denver, USA
Risk Based Computer Validation FDA's Initiatives for the 21st Century
Agilent ChemStation Plus Users Meeting

September 2, 2004
Labcompliance Audio Seminar
Writing Effective Test Scripts and Validation Protocols for the Bio/Pharmaceutical Industry CD Available
Learn from your desk or in your seminar room

August 18, 2004, Philadelphia, US
Laboratory Controls & Compliance
IVT Conference
Discussion session: Implementing International Regulations and Quality Standards

August 4 2004
Labcompliance Audio Seminar
Laboratory Equipment Qualification CD Available
Learn from your desk or in your seminar room

July 29, San Juan, PR, USA
College of Chemists - Annual Symposium
Cost Effective Validation of Software, Computer Systems, and Networks in Analytical Laboratories

July 29, San Juan, PR, USA
College of Chemists - Annual Symposium
Validation and Qualification in Analytical Laboratories

July 27, 2004
In house seminar - Pfizer Barceloneta
Update on FDA's Drug GMP Initiative and 21 CFR Part 11

July 27, 2004
In house seminar - Pfizer Barceloneta
Risk Based Validation of Software and Computer Systems

July 22, 2004
Labcompliance Audio Seminar
Master Planning for Computer Validation CD Available
Learn from your desk or in your seminar room

July 14, 2004
Labcompliance Audio Seminar
Writing Effective SOPs for the Healthcare Industry CD Available
Learn from your desk or in your seminar room

July 13, 2004
IVT Teleseminar
Ludwig Huber
Quo Vadis - Where is the FDA going with Part 11?

June 17, 2004
Labcompliance Audio Seminar
Successful FDA Inspections - Preparation, Conduct, Follow Up CD Available
Learn from your desk or in your seminar room

June 15, 2004
Ranbaxy Global Management Meeting - London
FDA's New Approach for Quality Systems and Risk Based Compliance

June 3, 2004
Labcompliance Audio Seminar
Configuration Management and Change Control of Computer Systems CD Available
Learn from your desk or in your seminar room

May 27, 2004
Labcompliance Audio Seminar
Risk Based Computer Validation and Part 11 Compliance CD Available
Learn from your desk or in your seminar room

May 26, 2004, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

May 24, 2004, Toronto, Canada
ASQ Annual Meeting
Ludwig Huber: plenary lecture
Risk Management For Regulated Software and Computer Systems

May 23, 2004, Toronto, Canada
ASQ Annual Meeting
Ludwig Huber: Full day workshop
Applying Risk Management to Computer Systems: Case Studies in Biomedical and Pharmaceuticals

May 13, 2004, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Validation of Electronic Records Systems
3) Case Studies: Definition and handling of raw data - Applications in manufacturing and laboratory control

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Plenary lecture:
Strategies to Define Part 11 Scope and Controls

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - 90 min Interactive discussion session:
My Computer System is High, Medium or Low Risk. What does this mean?

May 3/6, 2004, Washington DC
IVT Conference: E-records/signatures and computer validation
Ludwig Huber - Half day Workshop: Change Control and Configuration Management

April 29, 2004
Labcompliance Audio Seminar
Effective Training for FDA Compliance CD Available
Learn from your desk or in your seminar room

April 22, 2004
Labcompliance Audio Seminar
Validation of Software and Computer Systems in Analytical Laboratories CD Availablee
Learn from your desk or in your seminar room

April 8, 2004
IVT Teleseminar
Ludwig Huber
Risk Based Validation of Computer Systems

March 29, 2004, Amsterdam, The Netherlands
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Plenary lecture: The New Part 11 Guidance and its Effect on the Laboratory

March 29, 2004, Amsterdam, The Netherlands
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Workshop: Implementing Part 11 in Analytical Laboratories

March 25, 2004
Labcompliance Audio Seminar
Validation of Spreadsheets for Part11 and GxP Compliance CD Available
Learn from your desk or in your seminar room

March 23, 2004
Labcompliance Audio Seminar

FDA's 21 CFR Part 11

Requirements, New Scope and Recommendations for Implementation CD Available
Learn from your desk or in your seminar room

Feb 26, 2004, Singapore
GxP Week of IQPC
90 min Spotlight Session
How to Avoid FDA Inspection Observations and Warning Letters

Feb 25, 2004, Singapore
GxP Week of IQPC
90 min Spotlight Session
Validation of Computerized Systems and Software in Analytical Laboratories

February 19, 2004
Labcompliance Audio Seminar
Part 11 Case Studies CD Available
The Ultimate Answers and Tools You Need to Define and Document Your Part 11 Scope and Controls
Learn from your desk or in your seminar room

Feb 3/5, 2004, Amsterdam, The Netherlands
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: four presentations
1) Plenary lecture: FDA Requirements for Computer Systems, Networks, and IT Infrastructure
2) Interactive discussion session:
How to Avoid 483’s and Warning Letters Relating to Network Qualifications
3) Workshop: Keeping Networks 21 CFR Part 11 Compliant
4) Interactive discussion session: Developing test scripts and other Documentation for Infrastructure Qualification

Feb 2/5, 2004, Amsterdam, The Netherlands
IVT Conference: Validation Week
Ludwig Huber: three presentations
1) Plenary lecture: Pharmaceutical cGMP's for the 221st Century
2) Workshop: Navigating FDA's New Part 11 Guidance
3) Discussion session: Managing international laboratory compliance

Jan 28/29, 2004, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

Jan 27, 2004, Worldwide, Teleseminar
Strategies to Define Part 11 Scope and Controls
IVT

January 15, 2004
Labcompliance Audio Seminar
Using Excel in GxP/Part11 Environment CD Available
Learn from your desk or in your seminar room

Presentations in 2003 and before

December 19, 2003, Chennai, India
Annual Indian Pharmaceutical Congress (IPC)
Ludwig Huber: Plenary lecture
Recent GxP Initiatives in Europe and United States

December 18/19, 2003, Mumbai/Chennai, India
One day Agilent seminar
Risk Management for GxP and Part 11 Compliance

Dec 16, 2003, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Definition and handling of raw data: Applications in manufacturing and laboratory control

December 11, 2003
Labcompliance Audio Seminar
Cost effective Strategies for Network Compliance and System Uptime
Learn from your desk or in your seminar room CD Available

Nov 19, 2003, Worldwide, Teleseminar
Strategies to Optimize Costs vs. Risks for FDA's New Part 11 Guidance
IVT, CD available

Nov 19, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Word Processors and Docment Management Systems in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for Word Processors and Document Management Systems

Nov 18, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

November 17/18
Advanced Computer System Validation
SMI
Ludwig Huber: Plenary lecture - New Regulations and Guidance for Computer Systems: E-records/signatures

October 31, 2003, Beijing, China
Invited by the China FDA Headquarter for Half Day Seminar and Round Table Discussion
Ludwig Huber: Worldwide Trends in Compliance for the Pharmaceutical Industry

October 30, 2003, Beijing, China
Invited by Beijing's Science and Technology Commission for
Half Day Seminar and Round Table Discussion
Ludwig Huber: Worldwide Trends in Compliance for the Pharmaceutical Industry

October 29, 2003, Tokyo, Japan
Annual PDA Conference 2003
PDA Japan
Ludwig Huber: Plenary lecture - Risk Assessment for Part 11 and GxP Compliance

October 27 and 28, 2003, Agilent Technologies
Half day seminar series
October 27, Osaka, Japan
October 28, Tokyo, Japan

Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories

EU and US-FDA requirements for computer systems and e-records

Risk assessment for GxP and part11 compliance

Oct 6/8, Philadelphia
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: three presentations
1) Plenary lecture: FDA Requirements for Computer Systems, Networks, and IT Infrastructure
2) Interactive discussion session:
How to Avoid 483’s and Warning Letters Relating to Network Qualifications
3) Workshop: Keeping Networks 21 CFR Part 11 Compliant

October 1/2, 2003, Mannheim, Germany
FDA Conference 2003
European Compliance Academy
Ludwig Huber: Plenary lecture - New Directions for Part 11 - What's Next?

September 18, 2003, Vienna, Austria
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Ludwig Huber: Plenary lecture - Compliance of Network Infrastructure and Systems

September 17, 2003, Vienna, Austria
Update on FDA Requirements for Electronic records/signatures
European Compliance Academy
Ludwig Huber: Plenary lecture - Update on FDA Requirements for Laboratories

September 17, 2003, Vienna, Austria
FDA/EU Requirements for Laboratory Computers and Records
European Compliance Academy
Ludwig Huber: Pre-conference Workshop - Meeting FDA requirements for Electronic Records

September 16, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in part 11 environment
Half day workshop

September 16, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Lifecycle Planning for Software and Computer Validation
Half day workshop

September 15, 2003, Brussels, Belgium
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Impact of FDA's news risk based system inspections on part 11 and computer validation
Plenary lecture

August 19, 2003, Short Hills, NJ, USA
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Plenary lecture: The New Part 11 Guidance and its Effect on the Laboratory

Sep 12, 2003, Worldwide, Teleseminar
Implementing FDA's New Part 11 Final Guidance: Scope and Applications
IVT

August 18, 2003, Short Hills, NJ, USA
Laboratory Controls & Compliance
IVT Conference
Ludwig Huber: Workshop: Implementing Part 11 in Analytical Laboratories

August 14, 2003, San Francisco, CA, USA
IVT : International Seminar Series
Ludwig Huber: Network Infrastructure Qualification & System Validation
Full day workshop

August, 2003, Agilent Technologies
Half day seminar series
August 11: Indianapolis, ID
August 12: Chicago, IL
August 13: West Lake Village, CA
August 13: Anaheim, CA
August 15: San Francisco

Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories
The New Part 11 Guidance and Its Affect on the Laboratory
E-records/signatures: Validation of Computer Systems according to new FDA and EU guidelines Qualification of Network Infrastructure and Validation of Networked Data Systems

July 16, 2003, San Juan, Puerto Rico, Agilent Technologies Seminar
Half day seminar
Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories

The New Part 11 Guidance and Its Affect on the Laboratory
E-records/signatures: Validation of Computer Systems according to new FDA and EU guidelines
Validation of Network Data Systems for Part 11 Environment

July 1, 2003, Brussels, Belgium
Barnett Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Develop solutions for network configuration management and change control

June 30, 2003, Bruessel, Belgium
Barnett Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Using the Internet in a Regulated Environment

May 22, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Excel in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for MS Excel

May 21, 2003, Worldwide, Teleseminar
Impact on FDA's New Risk Based Approach on Part 11
IVT

May 21, 2003, Karlsruhe, Germany
PCS Seminar: Using Access in GMP Environment (in German)
Ludwig .Huber, EU and FDA GMP Requirements for MS Access

May 20, 2003, Karlsruhe, Germany (in German)
PCS Seminar: Using Word Processors and Docment Management Systems in GMP Environment
Ludwig .Huber, EU and FDA GMP Requirements for Word Processors and Document Management Systems

May 14, 2003, Orlando, FL, USA
FDA's Science and Risk Based GMP Inspections -
What does this mean for laboratories?
at the Agilent Technologies Networked Data Systems Users Meeting
Plenary lecture

May 13, 2003, Orlando, FL, USA
Impact of FDA's New Part 11 Guidance on Laboratories
at the Agilent Technologies Networked Data Systems Users Meeting
Half day workshop

May 12, 2003, Philadelphia, PA, USA,Park Hyatt
Develop Strategies for Converting to a Paperless Laboratory while Remaining in Complaince with FDA/EU Guidelines
at the Barnett conference : Laboratory Controls

May 12, 2003, Philadelphia, PA, USA,Park Hyatt
Understanding FDA Inspection trends for Laboratory Control
at the Barnett conference : Laboratory Controls

May 2, 2003, Chicago, USA
Impact of FDA's part 11 new guidance document on analytical laboratories
at the IIR conference : Laboratory Equipment Validation&Calibration
Plenary lecture

May 1, 2003, Chicago, USA
Impact of FDA's new Initiative on drug quality to laboratory equipment and part 11 compliance
at the IIR conference : Laboratory Equipment Validation&Calibration
Plenary lecture

April 30, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in part 11 environment
Half day workshop

April 29, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using macros and spreadsheets in a regulated environment
Half day workshop

April 28, 2003, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Impact of FDA's news risk based system inspections on part 11 and computer validation
Plenary lecture

April 16 and 17,2003: Internet Seminar
Design Qualification and Re-qualification
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

Mar 04, 2003, New Dehli, Mar 05, Ahmedabad, Mar 06, Chennai
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in three Indian cities:

Complying with International Regulations in the Pharmaceutical Industry

FDA and international regulations/guidelines for pharmaceutical development and QA

Validation of computer systems in laboratories

Electronic records/signature and 21 CFR Part 11 compliance

Analytical method validation

Feb 27, 2003, Tokyo, Japan
PDA Japan: 21 CFR Part 11 Task Force Meeting
Ludwig Huber, 4 presentations

FDA Update on 21 CFR Part 11

FDA's cGMP Initiative for science and risk based inspections: impact on part 11 and computer validation

API and 21 CFR Part 11

The impact of the part 11 guide 'Scope and Application' on chromatographic data systems

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Developing an Effective 21 CFR Part 11 Training Program Supporting Regulatory Compliance

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using the Internet in a Part 11 Regulated Environment

Feb 26, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment

Feb 25, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Qualification of network infrastructure and validation of networked systems

Feb 24, 2003, Tokyo, Japan
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Industry Guidances to Laboratory Computers

Feb 10/11, 2003, Philadelphia, Hyatt Hotel, PA, USA
Barnell Conference: Network Infrastructure Qualification & System Validation
Ludwig Huber: Develop solutions for network configuration management and change control

Jan 27/29, 2003
IVT Conference: Network Infrastructure Qualification and System Validation
Ludwig Huber: two presentations
1) Using the Internet in a Regulated Environment
2) Validation of Networked Systems

Jan 20, 2003, Singapore, Jan 22, Gouangzhou, Jan 23 Shanghai, Jan 24, Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in four Asian cities:
Complying with International Standards in the Pharmaceutical Industry
FDA and international regulations/guidelines for pharmaceutical development and QA
Validation of computer systems in laboratories
Electronic records/signature and 21 CFR Part 11 compliance
How an instrument vendor can help with compliance (by Yoko Gemba, YAN Japan)

Jan 20, 2003, Singapore, Jan 22 Guangzhou China, Jan 23 Shanghai, Jan 24 Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in four Asian cities:
Complying with International Standards in the Pharmaceutical Industry
FDA and international regulations/guidelines for pharmaceutical development and QA
Validation of computer systems in alboratories
Electronic records/signatures and 21 CFR Part 11 compliance
How an instrument vendor can help with compliance
Demonstration of software that helps to comply with the most recent regulations

Jan 16/17, 2003, Heidelberg, Germany (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

Presentations in 2002 and before

Dec 9, 2002, Amsterdam, The Netherlands, Radison Hotel
IIR: Workshop, half day
Ludwig Huber
Using Networks in a Part 11 Regulated Environment
Radisson SAS - Amsterdam

Dec 9/12, 2002, Amsterdam, The Netherlands
IIR conference: Electronic Signatures and 21CFR Part 11 Compliance
Ludwig Huber
Presentation: Ensuring compliance of a vendor purchased system

December 2-3, 2002, Barcelona Spain
GMP-/FDA Compliant Raw Data Management and Archiving
ECA Conference (European Compliance Academy)
Ludwig Huber: two presentations
1) FDA compliant RAW Data and other records
2) Raw data in quality control

Nov 20, 2002, Copenhagen, Denmark
Concept Heidelberg: Workshop, half day
Ludwig Huber
Implementing FDA’s 21 CFR Part 11: Electronic Records and Signatures

Nov 20/21, 2002, Copenhagen, Denmark
Concept Heidelberg conference: European Part 11 Conference
Ludwig Huber: two presentations
Using Networks in a Part 11 Regulated Environment
Long Term Archiving and Ready Retrieval of Electronic Records
With Preconference Workshop: Introduction to 21 CFR Part 11 (Speaker: Ludwig Huber)

Nov 10/11, 2002, Cologne, Germany (in German)
Concept Heidelberg conference: German Part 11 Conference
Ludwig Huber: two presentations (in German)
Qualification and Validation of Networks and Applications
Long Term Archiving and Ready Retrieval of Electronic Records

November 14/14: Internet Seminar
Laboratory Compliance with FDA’s Part 11 e-Records Maintenance Guidance
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

Oct 24, 2002, Berlin, Germany
Nugenesis, User Conference 2002
Ludwig Huber: Moving to the Paperless Laboratory - Regulatory and Business Aspects

Oct 23, 2002, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

Oct 7/8, Philadelphia
IVT Conference: Network Infrastructure Qualification
Ludwig Huber: two presentations
1) Using the Internet in a Regulated Environment
2) Validation of Networked Systems

October 2/4,
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Seminar with Ludwig Huber in East of United States and in Canada

Oct 1, Philadelphia
Pharmaceutical Education Associates (PEA): LabMation Conference
Ludwig Huber
Plenary Session: Latest FDA Regulations, Guidelines, Inspection and Enforcement Practices for Pharmaceutical Laboratories
Plenary lecture

Philadelphia, Sep 30 - Oct 2, 2002
Infrastructure Qualification and Network Validation
Center for Business Intelligence
Ludwig Huber: Regulatory Requirements for Change Management and Control

Sept 30, Philadelphia
Pharmaceutical Education Associates (PEA): LabMation Conference
Ludwig Huber
Design and Validation of Laboratory Computers and Data Systems for E-Records/E-Signature Compliance
Half day workshop

September 24, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Validation Guidance to Analytical Laboratory Computers
Half day interactive session

September 23, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Qualification of network infrastructure and validation of networked systems
Half day interactive session

September 23, Dublin, Ireland
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment
90 min Interactive session

June 13, Philadelphia, USA (full day)
LIMS 2002 Post Conference Workshop
Ludwig Huber
Implementing E-record&signature Compliance in Laboratory Data Systems and LIMS
One day Interactive session

June 10 - 19
Ludwig Huber, Agilent Technologies
Latest FDA regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Seminars with Ludwig Huber North America

May 31, Brussels, Belgium
Ludwig Huber, Agilent Technologies
Laboratory Equipment Qualification
IVT

May 16, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Using Macros and Spreadsheet programs in regulated environments

May 15, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Validation and Qualification of Networks and Networked Systems

May 15, 2002, London, UK
IBC Conference: Validation of Computer Systems,
Operational Compliance for Legacy Systems

April 24, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
How to Apply FDA's Recent Part 11 Interpretations and Validation Guidance to Analytical Laboratory Computers
Half day interactive session

April 24, Washington, USA
IVT Conference: E-records/signatures and computer validation
Ludwig Huber
Using Macros and Spreadsheets in Regulated Environment
90 min Interactive session

April 23, Washington, USA
IVT Conference: E-records/signatures and computer validation
Thomas Quinn and Ludwig Huber
Qualification of network infrastructure and validation of networked systems
Half day interactive session

April 10-12
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories

Computer validation including networked systems

21 CFR Part 11,

Method validation

Seminar with Ludwig Huber in East of United States

April 9, 2002, Philadelphia, PA, USA
Laboratory Equipment Validation&Calibration Conference IIR,
Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

April 8, 2002, Philadelphia, PA, USA
Validation and Qualification of Computerized Analytical Systems
at the IIR conference : Laboratory Equipment Validation&Calibration
Half day pre-conference workshop

March 21, 2002, Darmstadt, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

March 11 to 15, 2002, India: Mumbai, Bangalore, Hyderabad
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Overview: global regulations, Individual sessions on computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Three one day seminars with Ludwig Huber in Mumbai (11), Bangalore (13) and Hyderabad (15)

Mar 06, 2002, Berlin, Germany
Concept Heidelberg conference: Successful HPLC Management in a GMP-/FDA-Regulated Environment
Ludwig Huber: Regulatory requirements and enforcement practices for HPLC

Feb 22, 2002, Tsukuba, Japan
Agilent Seminar for Yamanouchi company: E-records/signatures/Validation
1) Qualifying network hardware and software in networked systems
2) Design and validate a chromatographic data system for compliance with 21 CFR Part 11: FDA's inspection findings, enforcement practices, and recommended responses for 21 CFR Part 11 in Chromatographic Data Systems

Feb 21, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Response of the Pharmaceutical Industry in Europe and in United States to 21 CFR Part 11

Feb 21, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Design and Validation of Chromatographic Data Systems for 21 CFR Part 11

Feb 20, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Understanding Recent Part 11 guidance documents

Feb 20, 2002, Tokyo, Japan
IVT Conference: E-records/signatures
Part 11 Compliance with Audit Trail Requirements of Part 11

Feb 19, 2001, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Operational Compliance for Legacy Systems

Feb 19, 2002, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Validation and Qualification of Networks and Networked Systems

February 15, 2002, London, UK
IBC conference: InfoTech Pharma 2002
Ludwig Huber: Key Note presentation
Update on regulations and guidelines in US and EU

February, March, April 2002: Internet Seminar Series
21 CFR Part 11 and Computer Validation
The FDA has published draft guidance document on validation for part 11. In addition, a lot of other papers have been published on 21 CFR part 11. In response to this Agilent Technologies will run a series of on-line seminars to discuss what these new documents mean for analytical laboratories. Seminars are scheduled for European and American time zones. The seminars are free.
The seminars will be developed and/or presented by Ludwig Huber.
For abstracts, dates and registrations click on the titles to visit the Agilent on-line seminar website
(EUROPE) Impact of FDA's 21CFR11 Validation Guidance on Pharmaceutical Laboratories
(AMERICA) Impact of FDA's Part 11 - Validation Guidance for Pharmaceutical Laboratories (AMERICA) Review of the latest Information on the Application and Enforcement of FDA 21CFR Part 11
(AMERICA) Complying with FDA 21CFR11 using Agilent's ChemStation Plus
(EUROPE) Review of the Latest Information on the Application and Enforcement of 21 CFR Part 11
Attendees should have a good understanding on basics of computer validation and 21 CFR Part 11. As pre-study material attendees can order free literature from the LabCompliance literature service.

January 15/16, 2002, Heidelberg, Germany
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs (in German)
Ludwig Huber: two presentations
Validation and Qualification of Analytical Equipment
Validation and Qualification of Computer Systems

January 14 2002, London, UK
SMI conference: Laboratory Equipment Validation
Ludwig Huber:
Design and validation of chromatographic data systems

Presentations in 2001 and before

 

Dec 11, 2001, Heidelberg, Germany
Concept Heidelberg conference: FDA/EU GMP Compliant raw data and archiving (in German)
Ludwig Huber: three presentations
1) FDA compliant RAW Data and other records
2) Change of data - audit trail
3) Applications in quality control

Dec 4, 2001, Stuttgart, Germany
PCS Conference: Validation of Computerized Systems
Ludwig Huber: Validation of analytical systems and data evaluation software (in German)

Nov 14, 2001,
Ludwig Huber, Agilent Technologies
Application of Part 11 for selected computer systems in manufacturing and laboratories
Presented at Pharmacia-Upjohn, United States

Nov 5-14, 2001,
Ludwig Huber, Agilent Technologies
Latest FDA and European regulations, guidelines, inspection and enforcement practices for pharmaceutical laboratories
Computer validation including networked systems, 21 CFR Part 11, Method validation: supported by video clips with FDA speakers
Eight one day seminars with Ludwig Huber in California and Midwest, United States

Oct 23, 2001,
Co-sponsored by Agilent Technologies and Pharmaceutical Society Korea:
Latest regulations, guidelines, inspection and enforcement practices for the pharmaceutical laboratory
One day seminar with Ludwig Huber
For details: click here

Oct 17, 2001, Tokyo, Japan
IVT Conference: E-records/signatures
Part 11 Compliance with Audit Trail Requirements of Part 11

Oct 16, 2001, Tokyo, Japan
IVT Conference: Validation of Software and Computer Systems,
Operational Compliance for Legacy Systems

Oct 16, 2001, Tokyo, Japan (
IVT Conference: Validation of Software and Computer Systems,
Validation and Qualification of Networks and Networked Systems

Oct 15, 2001, Tokyo, Japan
IVT Conference: Laboratory Equipment Qualification and Validation,
Design and Validate a Chromatographic Data System for Compliance with FDA's 21 CFR Part 11

Sept 25-28, 2001,
Co-sponsored by Agilent Technologies, Pharmacia, AstraZeneca, Pharmaceutical Society Denmark:
Latest regulations, guidelines, inspection and enforcement practices for the pharmaceutical laboratory
Four one day seminars with Ludwig Huber in Finland, Schweden (2) and Denmark
For details: click here

Jul 24, 2001, Kuala Lumpur, Malaysia
Seminar cosponsored by the National Pharmaceutical Control Burea, the Ministry of Health Clinical Investigation Centre Malaysia, The University Malaya Medical Centre and Agilent Malaysia
Objectives and Trends for Quality Systems - CGMP/GLP/ISO17025

Jul 23, 2001, Singapore, Jul 25 Kuala Lumpur, Jul 27 Bangkok, Jul 31 Taipei, Aug 2 Beijing
Agilent Technologies Asian Compliance Seminar Tour
One day seminars in five Asian countries:
Implementing ISO 17025 and GLP/GMP in Analytical Laboratories
Overview of regulations and quality standards with impact on analytical laboratories
Validation and qualification of analytical equipment and computers
Validation of analytical methods: New ICH, USP, FDA guidelines

How to comply with most recent requirements of ISO 17025 and regulations:
e.g., measurement uncertainty, 21 CFR Part 11

Case studies using computerized HPLC equipment and methods as examples
July 24, 2001, Singapore, Agilent Technologies Seminar
Half day seminar
Recent regulations/guidelines, inspection and enforcement trends for pharmaceutical laboratories
Overview: new regulations, guidelines, US FDA's/EU inspection and enforcement practices, industry's response
E-records/signatures: FDA's 21 CFR Part 11, European initiatives
Validation of analytical equipment and computer systems
Validation of analytical methods: New ICH, USP, FDA guidelines

June 27, 2001, Orlando, FL
Agilent Technologies Networked Data Systems Users Meeting, Operational Compliance of Legacy Systems

June 27, 2001, Orlando, FL
Agilent Technologies Networked Data Systems Users Meeting, Update on compliance: new regulations, guidelines, inspection and enforcement practices in America and Europe

June 26, 2001, Philadelphia, PA, USA
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

Users of chromatographic data systems experience specific problems with 21 CFR part 11 (electronic records and signatures). This presentation provides an overall strategy and specific examples on how to specify, install, validate and operate such systems in compliance with the rule. This presentation addresses the following topics:
Definition of raw data and meta data for signals and spectra
Recording and long-term archiving and ready retrieval of data including meta-data
Audit trails of multiple data reprocessing
Binding signatures with the electronic records
Log-on multiple users on PC controlled multi-instrument systems
Validation of hybrid chromatographic systems

June 25, 2001, Philadelphia, PA, USA
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

Using practical examples, this workshop guides QA and laboratory managers and users of computer controlled analytical instruments through the entire validation process, from design and vendor qualification, through installation qualification, operational qualification and performance qualification. It gives practical recommendations on how to speed up the validation processes and how to do it 'right' the first time, thus building confidence for audits and inspections and avoiding troublesome rework. This workshop provides clear step-by-step instructions on:
Developing a validation master plan
Developing user requirement and functional specifications (DQ)
Selecting and qualifying a vendor
Testing and documentation for installation and operational qualification (IQ,OQ)
Testing for on-going performance qualification (PQ)
Evaluation and validation of existing systems
Revalidation after hardware repair and after firmware and software updates
Validation of user contributed software, e.g., Macros
Validation for FDA's 21 CFR Part 11 compliance
Preparing for inspections
This workshop is designed for maximum interaction between the speakers and delegates. Delegates are strongly encouraged to participate in workshop discussions.


June 22, 2001, Philadelphia, PA, USA
Barnett International
Workshop: FDA Compliance for Computerized Spectroscopy Systems

Part 1. Validation of Computerized Spectroscopy Systems

Session Description:
While in the past the FDA was focusing more on inspection of equipment hardware and analytical methods, now they pay more attention on laboratory computer systems. Using specific case studies, this presentation will give an overall strategy but also focus on most critical points such as worst case testing and change control. Using examples from analytical laboratory with stand-alone and networked computer systems attendees will learn:
About recent FDA 483's and Warning letters for computer systems and laboratory networks
How to develop a validation strategy master plan
How to get the most help from suppliers
How to perform IQ/OQ/PQ most cost effectively
How to manage change control
Implementation for spectroscopy systems

June 22, 2001, Philadelphia, PA, USA
Barnett International
Workshop:FDA Compliance for Computerized Spectroscopy Systems
Part 2: Upgrading Spectroscopy Systems to FDA Part 11 Compliance

Users of computerized analytical systems experience specific problems with 21 CFR part 11 (electronic records and signatures). This presentation provides an overall strategy and specific examples for spectroscopy systems on how to specify, select, install, validate and operate such systems in compliance with the rule. This presentation addresses the following topics:
FDA's inspection and enforcement practices
Definition of raw data and meta data
Long-term archiving and ready retrieval of data including meta-data
How to comply with audit trail requirements
Strategy for existing spectroscopy systems
Gap analysis and implementation plan

May 31, 2001, Sidney, Australia
RACI PHARMACEUTICAL SCIENCE GROUP (NSW)
Method Development and HPLC Analytical Validations (including impurities)

May 31, 2001, Sidney, Australia
RACI PHARMACEUTICAL SCIENCE GROUP (NSW)
Analytical Instrumentation - Computer Validations and Security - CFR11 issues

May 29, 2001 and May 30, 2001 Melbourne, Australia
Agilent Technologies Australian Quality&Compliance Seminar Tour
Three half day seminars at Fauldings Pharmaceutical, Sigma and CSL

Implementing Quality and Compliance in Pharmaceutical Laboratories
Validation and qualification of analytical equipment and computers
Design and validation of chromatographic data systems for 21 CFR Part 11 compliance
Validation of analytical methods: New ICH, USP, FDA guidelines

May 28 2001, Brisbane, Australia
Agilent Technologies Australian Quality&Compliance Seminar Tour
Half day seminar
Implementing Quality and Compliance in Analytical Laboratories
Overview of regulations and quality standards with impact on analytical laboratories
GLP/GMP/ISO17025
Validation and qualification of analytical equipment and computers
Validation of analytical methods: New ICH, USP, FDA guidelines

May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, FDA Expectations for 21 CFR Part 11

April 26/27, 2001, Philadelphia, USA
May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, Validation of Computerized Systems & Laboratory Networks

While in the past the FDA was focusing more on inspection of equipment hardware and analytical methods, now they pay more attention on laboratory computer systems and most recently also on Networks. Using specific case studies, this presentation will give an overall strategy but also focus on most critical points such as worst case testing and change control. Using examples from analytical laboratory with stand-alone and networked computer systems attendees will learn:
About recent FDA 483's and Warning letters for computer systems and networks
How to develop a validation strategy master plan
How to get the most help from suppliers
How to perform IQ/OQ/PQ most cost effectively
What and how much to test on a network
How to manage change control

April 26/27, 2001, Philadelphia, USA
May 24/25, 2001, London, UK
Institute of Validation and Technology
Two day conference, "Laboratory Equipment":
L.Huber, GAMP Initiatives for Computerized Laboratory Systems

The Good Automated Manufacturing Practices (GAMP) Forum exists to promote the understanding of the regulation and use of computers within the pharmaceutical industry. The forum has done an excellent job on developing industry guidelines for software and computer validation. While FDA regulations say what to do, GAMP guidelines tell very much in detail on how to implement regulations and to reduce business risks. They are increasingly used throughout the world in preparation for regulatory inspections and for vendor audits. Currently there are three main (draft) documents available: Validation of Automated Systems, 21 CFR Part 11, and IT infrastructure quality. In addition there are special interest groups on selected topics, such as laboratory equipment. This presentation explains the key points of the documents from a practical view and how they can help to comply most effectively in laboratories.
Attendees will learn about:
GAMP initiatives and guidelines, where to get the documents
GAMP computer system classifications with examples from the laboratory
GAMP approach to successful and cost effective validation of automated systems
Using the GAMP approach to upgrade a laboratory to part 11
What can we learn from special interest groups

March 28/29, 2001, London, UK
Business Intelligence
Two day conference: Computer Systems Validation
L.Huber: Operational Compliance for Legacy Systems

Legacy systems are those that have been designed, developed and/or used before regulations have been in place or enforced. Compliance for them is more difficult than for new systems. Most important for legacy systems is to develop and implement a corrective action plan with time schedules, owners and checkpoints. . In this presentation we will cover:

FDA's enforcement practices for legacy systems, recent examples of inspectional observations and warning letters
Development of a compliance master plan for legacy systems
System inventories and gap analysis
Setting priorities based on impact on product quality and nature and extend of non-compliance
Development and implementing technical and procedural controls to comply with part 11
Steps for retrospective validation: Setting specifications, IQ, OQ
Effective change management

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Comply with Audit Trail Requirements
Even though audit trail it self is nothing new for FDA regulated environments it is the most frequently discussed requirement of part 11. There are two reasons for this: 1. Missing software to meet the new requirement to generate the audit trail by the computer independently from the operator and 2) Uncertainty on when audit trail should start and what it should include.

Using practical examples from laboratories, production control and office area, attendees will learn:
FDA's requirements and enforcement practices
What should be included in the audit trail
The level of detail
When audit trail should start in a document development chain
How to link audit trails with other electronic records to ensure authenticity
What to do in case software providers do not offer audit trail functionality
User requirement and functional specifications for audit trails

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, 21 CFR Part 11, Basic requirements and impact on chromatographic data systems

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Qualification of Networks and Validation on Networked Systems

March 27, 2001, Cork, Ireland
Seminar at Pfizer
L.Huber, Validation of computerized Analytical Ststems

March 6/7, 2001, Baden-Baden, Germany
Pharmaceutical Training Services
Two day conference, "Validation in Laboratories":
L.Huber, Half day workshop: Validation and qualification of equipment (in german)

Feb 21, 2001, London, USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures":
L.Huber, Comply with Audit Trail Requirements

Even though audit trail it self is nothing new for FDA regulated environments it is the most frequently discussed requirement of part 11. There are two reasons for this: 1. Missing software to meet the new requirement to generate the audit trail by the computer independently from the operator and 2) Uncertainty on when audit trail should start and what it should include.

Using practical examples from laboratories, production control and office area, attendees will learn:
FDA's requirements and enforcement practices
What should be included in the audit trail
The level of detail
When audit trail should start in a document development chain
How to link audit trails with other electronic records to ensure authenticity
What to do in case software providers do not offer audit trail functionality
User requirement and functional specifications for audit trails

Feb 21, 2001, London, USA
Institute of Validation and Technology
Two day conference, "Computer Validation":
L.Huber, Validation and Qualification of Databases and Networks

Most recently the FDA pays much attention to the validation of Networks in laboratories and production control. For example, in summer this year a five page 483 inspectional observation on missing or incomplete validation of a Local Area Network and a Wide Area Network has been issued by the FDA. Validation of networks is not only important to meet FDA requirements but to meet business requirements. For example, it can be a disaster for a company if complete databases are lost because of a non-validated back-up or disaster recovery procedure. On the other hand it is obvious that in a complex network not all possible combinations can be tested, so optimizing risk vs. cost is important.

Using a Laboratory Network as an example, attendees will learn
About FDA's inspectional observations on networks
How to get the most help from the supplier
What and how to test during installation and operation (IQ/OQ)
How to ensure on-going performance (PQ)
How to validate functions as required by 21 CFR part 11
Risk assessment versus costs, e.g., how many clients should be tested
Validating back-up and recovery procedures

Jan 30, 2001, Ulm, Germany
Merckle
L.Huber, Update on 21 CFR Part 11: FDA and Industry Initiatives

Jan 24, 2001, Washington, USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures":
L.Huber, Comply with Audit Trail Requirements

Jan 23, 2001, and Feb 20, 2001

Implementing 21 CFR Part 11 - An Overview w/ Recommendations for the Analytical Laboratory, Web seminar: Agilent Technologies

The FDA rule on electronic signatures and records has been in effect since 1997, but only recently have they been enforced. Although the rules are well documented, there is still confusion in regulated industry about implementation. This seminar, the first in a series of five, the series, will give overall strategies and practical examples for implementation in the chromatographic laboratory.

Jan 22, 2001, Washington, USA
Institute of Validation and Technology
Two day conference, "Computer Validation":
L.Huber, Validation and Qualification of Databases and Networks

January 16, 2001, Darmstadt, Germany
Validation and Qualification of Analytical Equipment (in German)
Validation and Qualification of Computer Systems (in German)
Qualification of HPLC and GC Systems (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs

Presentations in 2000and before

 
November 13, 2000, San Diego, CA, USA
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

November 14, 2000, San Diego, USA
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

Using practical examples, this workshop guides QA and laboratory managers and users of computer controlled analytical instruments through the entire validation process, from design and vendor qualification, through installation qualification, operational qualification and performance qualification. It gives practical recommendations on how to speed up the validation processes and how to do it 'right' the first time, thus building confidence for audits and inspections and avoiding troublesome rework. This workshop provides clear step-by-step instructions on:
Developing a validation master plan
Developing user requirement and functional specifications (DQ)
Selecting and qualifying a vendor
Testing and documentation for installation and operational qualification (IQ,OQ)
Testing for on-going performance qualification (PQ)
Evaluation and validation of existing systems
Revalidation after hardware repair and after firmware and software updates
Validation of user contributed software, e.g., Macros
Validation for FDA's 21 CFR Part 11 compliance
Preparing for inspections

This workshop is designed for maximum interaction between the speakers and delegates. Delegates are strongly encouraged to participate in workshop discussions.

Nov 9/10, 2000, Basel, Switzerland
L. Huber, Impact of Part 11 on Analytical Laboratories, AVP Symposium on Electronic Records/Signatures

Nov 15/16, London, United Kingdom
Moving LIMS from Handwritten Signatures to 21 CFR Part 11 Compliant E-signatures and E-records, EU LIMS 2000 Conference

Oct 27, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

Oct 23, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

Oct 16/18, 2000, Boston, USA
ISLAR, Data management / 21CFR Part 11 Session
L. Huber, Data Management and CFR 21 Part 11 for Networked Chromatography Data Systems

Oct 6, 2000, Copenhagen, Denmark
L. Huber, Developing an 'Active' Implementation Plan for Part 11

Oct 5, 2000, Copenhagen, Denmark
L. Huber, 21 CFR Part 11 - Three Years After Release, ECA Conference: FDA's 21 CFR Part 11 on E-Records/Signatures in Laboratories

Sept 28, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Laboratory Equipment/Instrumentation Validation":
L.Huber, Validation of Software and Computerized Analytical Systems

Sept 28, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Laboratory Equipment/Instrumentation Validation":
L.Huber, Review Validation Data and Documentation for Instrument/Equipment Validation

Sept 27, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Investigating OOS Test Results":
L.Huber, Avoiding Out-of-Specification Situations.

By far the best way to deal with OOS situations most effectively is to avoid them as much as possible. OOS can have two main reasons: uncontrolled production processes or raw materials and laboratory errors. This presentation demonstrates how OOS situations caused by laboratory errors can be minimized through tight control of the laboratory processes. Upcoming out of control situations can be predicted and therefore avoided by regular analysis of quality control samples and graphical evaluation of quality control samples. Parameters to be controlled and evaluated are not only sample amounts but much more the ones which most likely cause out of control situations. These can be critical instrument parameters or unstable consumables and maintenance parts. Other mechanisms to avoid OOS include early maintenance feed back systems (EMF) as built into the laboratory equipment.

Sept 26, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Case study: Upgrading a pharmaceutical laboratory to part 11 compliance.

Sept 26, 2000, Dublin, Ireland
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Data migration, long term archiving and ready retrieval.

Sept 19, 2000, Osaka and Sept 20, Tokyo, Japan
YAN-Agilent Compliance seminar
L.Huber, FDA's 21 CFR Part 11 on E-signatures/records - Three years after release.

Sept 19, 2000, Osaka, and Sept 20, Tokyo, Japan
YAN-Agilent Compliance seminar
L.Huber, Case study, Upgrading a Pharmaceutical Laboratory to Part 11 compliance

Sept 16, 2000, Mumbai, India
Indian Drug Manufacturers' Association (IDMA), Annual convention
L.Huber, Key Note address, US FDA and International Trends in GLP and GMP Regulations

Sept 15, 2000, Mumbai, India
Electronic Records and Signatures in Pharmaceutical Laboratories , Agilent Technologies,
Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
Validation in Pharmaceutical Laboratories , Agilent Technologies,
Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
Case study: Upgrading computerized pharmaceutical laboratory to GLP/GMP compliance, Agilent Technologies, Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 15, 2000, Mumbai, India
International and US FDA trends in pharmaceutical GLP/GMP regulations, Agilent Technologies, Part of one day seminar: Recent developments in pharmaceutical regulations

Sept 13, 2000
One day conference, "Electronic Signatures in Europe", PTS, Mannheim, Germany
L.Huber, Electronic Signatures in Laboratories.

Sept 12, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

August 14/15, 2000, Washington D.C., USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Case study: Upgrading a pharmaceutical laboratory to part 11 compliance.

August 14/15, 2000, Washington D.C., USA
Institute of Validation and Technology
Two day conference, "Electronic Records and Signatures: Case Study Forum":
L.Huber, Data migration and long term archiving for ready retrieval.

July 28, 2000, One Day Workshop at the at the Chulalongkorn University, Bangkok, Thailand
Validation Processes in Analytical Laboratories

July 27, 2000, One Day Workshop at the at the Chulalongkorn University, Bangkok, Thailand
Implementing Quality Assurance in Analytical Laboratories

July 26, 2000, Shanghai, China, Shanghai Drug Control
GLP and GMP in Analytical Laboratories , half day seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Electronic Records and Signatures in Pharmaceutical Laboratories , Agilent Technologies, Shanghai Branch, MNC Seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Validation in the pharmaceutical industry, Agilent Technologies, Shanghai Branch, MNC Seminar

July 25, 2000, Shanghai, China, Hotel Sofietel
Trends in pharmaceutical GLP/GMP regulations, Agilent Technologies, Shanghai Branch, MNC Seminar

July 17, 2000, Comply with 21 CFR Part 11, Technologies

July 11, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

July 5, 2000, London, UK
L. Huber, Vendor Contributions for Computer Validation, SMI Conference: The Validation of Corporate IT Systems in the Pharmaceutical Industry

July 5, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

July 4, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

June 30, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

June 28, 2000, Antwerp, Belgium
L. Huber, Vendor Contributions for 21 CFR Part 11, GAMP Forum

June 20, 2000, London, United Kingdom
IBC Conference on Computer Validation, 21 CFR Part 11: FDA's Recent Inspection and Enforcement Practices

June 13, 2000, San Juan, Puerto Rico
Laboratory Equipment Validation&Calibration Conference IIR, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

June 12, 2000, San Juan, Puerto Rico
Half Day Preconference Workshop: Validation and Qualification of Computerized Analytical Systems, at the IIR conference : Laboratory Equipment Validation&Calibration

May 18, 2000, RTP, NC, USA
New Trends and Developments in Regulations HPLC for Pharmaceutical Industry, Dinner Presentation, Agilent Technologies, Raleigh NC

May 16, 2000, Atlantic City, USA
Moving LIMS from Handwritten Signatures to 21 CFR Part 11 Compliant E-signatures and E-records, LIMS 2000 Conference

May 11, 2000, Comply with 21 CFR Part 11, Web seminar: Agilent Technologies

May 10, 2000, Amsterdam, The Netherlands
Analytical Equipment Qualification as Prerequisite for Method Validation, APV Conference: Analytical Method Validation

April 27/28, 2000, Philadelphia, PA, USA
Two day conference, Electronic signatures and records, implementing part 11:
L.Huber, How to Deal with Chromatographic Hybrid Systems for Part 11.

Feb 16 to Mar 3, 2000, E-records and E-signatures Overview and Review of FDA Enforcement Trends

Feb 22/23, 2000, London, UK
Two day conference, Electronic signatures and records, implementing part 11:
How to Deal with Chromatographic Hybrid Systems for Part 11.

Feb 3, 2000, Bangkok, Thailand
Half Day Seminar, Implementing the new ISO 17025 Quality and Accreditation Standard in Analytical Laboratories

January 27/28, 2000, Singapore
L. Huber, US FDA and International Regulations and Guidelines for Analytical Laboratories: Update, Presented at Agilent Singapore

January 12, 2000, Darmstadt, Germany
Validation and Qualification of Analytical Equipment (in German)
Validation and Qualification of Computer Systems (in German)
Qualification of HPLC and GC Systems (in German)
Concept-Heidelberg Seminar: Calibration and Qualification in Pharmaceutical QC Labs

Presentations in 1999 and before

November 29/30, London, UK
L.Huber, Moving from paper to compliant electronic signatures and records, LG/GC International, Spectroscopy and Scientific Data Management Conference on new applications for greater productivity in Quality Control etc.

December 17, 1999, London, UK (postponed until 2000)
L.Huber, Design of Analytical Equipment for Compliance, LGC Conference on Equipment Qualification

November 17-19, Dublin, Ireland
L.Huber, Requirements and Enforcement Practices of 21 CFR Part 11, presented at the Agilent Seminar "Implementing 21 CFR Part 11 for Chromatographic Data Systems"

November 11, Groton, Connecticut, USA
Seminar at Pfizer, Moving Chromatographic Data Systems from Paper to Electronic Records and Signatures
Part 1: Regulation and Enforcement Practices
Part 2. Understanding and Implementing Administrative and Technical Controls

November 8/10, Miami
Laboratory Equipment Validation&Calibration Conference IIR, L. Huber, Design and Validation of Chromatographic Data Systems for Compliance with 21 CFR Part 21 (Electronic records/signatures)

September 30, 1999, Toronto, Canada
Canadian Validation and Calibration Symposium, L.Huber, Validation of computer systems and software in analytical laboratories

September 22, 1999, Berlin, Germany
One day international seminar: FDA requirements to computers in analytical lab, including computer validation, electronic records, electronic signatures. 21CFR11, L. Huber chairman and main speaker: two presentations:
Update on regulations and FDA's inspection practices and Preparing inspection ready documentation (in German)

September 26/27, 1999, Mannheim, Germany
Validation in Analytical Laboratories, national conference, L.Huber
Validation of computer systems in analytical laboratories (in German)

August 26/27, 1999, Washington, United States
Two day conference, Electronic signatures and records: L.Huber, Workshop leader: how to deal with chromatographic hybrid systems

April 13 and April 15
Oaska and Toko, Japan
L.Huber, Implementing validation of standalone computer systems and networks, Developing a validation plan, writing a design qualification, , validating Vendors, IQ/OQ testing, performance qualification, retrospective validation of existing systems.

April 23, 1999
Taipei, Taiwan
1 day workshop Validation and qualification in analytical laboratories

April 19, Singapore
L.Huber, 21CFRPart 11, Electronic records and signatures: What does it mean for equipment and software vendors?

April 7, Basel, Switzerland
Novartis
L.Huber, half day seminar, Validation and qualification of analytical equipment and systems

April 28, Mannheim, Germany
Concept -Heidelberg
1 Day seminar: FDA requirements for Pharma QA/QC labs, L.Huber, Raw Data in Chromatography

May 19, 1999, Saarbruecken, Germany
1 day seminar
L.Huber, Validation of Computerized Analytical Systems
Seminar Klinkner&Partner

January 27, 1999, Weest, The Netherlands
L.Huber, Moving from paper to electronic records, 21 CFR Part 11 , Solvay seminar

January 27, 1999, Weest, The Netherlands
L.Huber, System life cycle, Solvay seminar

December 2, 1998, Darmstadt, Germany (in German)
L.Huber, One day seminar: FDA requirements to computers: regulations, validation, electronic signatures, data traceability and integrity, Concept Heidelberg

January 19, 1999, Darmstadt, Germany
L.Huber, The Role of the Vendor for Equipment Calibration and Qualification, Concept Heidelberg.

Presentations in 1998 and before

 

December 3, 1998, Berlin, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

March 19, 1998, Waldbronn, Germany
L.Huber, Laboratory accreditation: New ISO Guide 25 and its impact on analytical laboratories, Hewlett-Packard Seminar

February 10, 1998, Mannheim, Germany
L.Huber, Validation of LIMS, PTS LIMS Seminar.

February 17, 1998, Darmstadt, Germany
L.Huber, The Role of the Vendor in Equipment Qualification, Concept Heidelberg Seminar: Calibration and Qualification of Analytical Equipment

May 19, Saarbruecken Germany
L.Huber, Validation of Computerized Systems, One day seminar, Klinkner&Partner, in German.

May 14, 1998, Essen, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

May 5, 1998, Singapore
L. Huber, International Regulations and Quality Standards -
Impact on Analytical Laboratories,
Presented at a Hewlett-Packard Seminar

Presentations in 1997 and before

December 11, 1997, Darmstadt, Germany
L.Huber, Application of Computers in Regulated Environments, One day Seminar, Concept Heidelberg, in German.

November 25/26, 1997, Strasbourg, France
L.Huber, The Role of the Vendor for Equipment Calibration and Qualification, International Symposium on Equipment Calibration and Qualification, Concept Heidelberg.

November 20, 1997, Essen, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik, in German.

November 3, 1997, San Jose, Costa Rica
L.Huber, Validation of analytical equipment and methods to meet GLP and GMP requirements in pharmaceutical laboratories, Pan American Pharmaceutical Symposium

November 5, 1997, Mexico City, Mexico
L.Huber, Validation of analytical equipment and methods, Hewlett-Packard Seminar

October 2, 1997, Toronto, Canada
L. Huber, System Validation and System Suitability Testing, Canadian Calibration and Validation Group: Annual Symposium 1997.

Oct 3, 1997,
L.Huber, Quality Assurance during software development GlaxoWellcome Seminar, Toronto Canada

September 23, 1997, Seoul, Korea
L. Huber, International Regulations and Quality Standards, National Korean GLP/GMP Symposium, Interface.

April 28/29, 1997, Moris Plaints, NJ, USA
L.Huber, The HP Chemical Analysis Group Software Quality System, Warner Lambert Computer Validation Symposium.

May 14/15, 1997, Berlin, Germany
L.Huber, Validation of Computer Systems in Analytical Laboratories, Seminar: Dr.Klinkner: Validation in Analytical Laboratories, Haus der Technik.

June 21/23, 1997, Buenos Aires, Argentina
L.Huber, Validating automated analytical equipment and methods, Second International Symposium of the Latin American and Caribbean Section of AOAC International.

June 24, 1997, Sao Paulo, Brazil
L.Huber, Establishing GLP and GMP Systems in a Laboratory, Hewlett-Packard Seminar.

June 25, 1997, Rio de Janeiro, Brazil
L.Huber, Easy and Trouble free Validation and Qualification of Analytical Equipment , Hewlett-Packard Seminar.

July 25, 1997, Konstanz, Germany
L.Huber, Validation of Computerized Analytical Systems, Byk Gulden Validation Seminar.

Presentations in 1996 and before

March 26 and May 29, 1996, Essen, Germany
L. Huber, The OECD Consensus paper - Applications of GLP to computerized Systems:
Responsibilities of Vendors, Presented at the Training for GLP Inspectors in Germany on "GLP and Electronic Data Handling"

October 21/22, 1996, London,
L. Huber, Validating computerized systems: impact of the new OECD consensus document on pharmaceutical laboratories, Pharmanalyis Europe, Advanstar Communications

October 27/28, 1996, Antwerp, Belgium,
L. Huber, How an instrument vendor helps with accreditation and ISO certification, Presented at Quality [R]evolution in Clinical Laboratories, Congress Makers

Seoul and Zagreb1996,
L. Huber, Establishing a quality system in a laboratory, Presented at Hewlett-Packard Seminars

Slovakia, Oct. 24/26 1996,
L. Huber, Quality assurance and instrumentation,
International AOAC/EURACHEM Workshop on Laboratory Quality Assurance, Accreditation and Reference Materials, Smolenice,

Prague, Seoul, Bombay and Bangkok in 1996,
L. Huber, Establishing GLP and GMP Systems in a Laboratory, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, The Application of the Principles of GLP and GMP to Computerized Systems, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, Easy and trouble free validation and qualification of analytical equipment, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo and Osaka in 1996,
L. Huber, Method validation and system suitability testing - now and in the future, USP and ICH guidelines, Presented at Hewlett-Packard Seminars

Presentations in 1995 and before

Frankfurt, Germany, November 3, 1994,
L. Huber, International aspects of computer validation in regulated environments, Dechema Meeting

Frankfurt, November 5, 1994,
L. Huber, Computer aided validation and analytical quality assurance, Seminar: Validation of analysis methods (to meet the new EC directive on food control - 93/99/EEC), organized by the German Chemical Society

Rome, December 5/7, 1994,
L. Huber and M. Zanetti, Validating automated analytical instruments to meet regulatory and quality standard requirements, Symposium: Analytical Quality Control and Reference Materials

Frankfurt, February 14, 1995,
L. Huber, Validation of computer controlled analytical equipment to meet regulatory requirements, Meeting of the Verband der Feinmechanischen und Optischen Industrie

Essen, Germany, February 22, 1995,
L. Huber, Quality assurance and validation of analytical equipment, Seminar of Dr. Klinkner on 'Validation in the Analytical Laboratory', Haus der Technik

Manchester, UK, February 23, 1995,
L. Huber, Validation of computer controlled analytical equipment, Seminar of the British Royal Society of Chemistry (RCS): Validation of Analytical Methods for Industry: Is it a problem ?

Cologne, Germany, organized by Prof. Dr. Donike, March 23, 1995,
L. Huber, Good laboratory practice in doping control, IOC Accreditation Symposium

April 24/25, 1995 Düsseldorf, Germany,
L. Huber, Validation of computer controlled analytical systems in the pharmaceutical laboratory, Pharmanalysis organized by Advanstar Communications

Innsbruck, Austria, May 1995,
A. Fell, L. Huber, B. Hancock, Validation in HPLC and CE, Moderators of Panel Discussion Session, HPLC 95

Nov. 28/29, 1996, Mannheim, Germany,
Morkowski, Huber, Kromidas, Validation, Moderator of a workshop at Quality in Analysis

Jan. 24/25, 1996 and Sept 18/19, 1996, Mannheim, in German,
L. Huber, Contributions of Instrument manufacturers for qualification and calibration, Presented at Calibration and qualification of analytical instruments in pharmaceutical quality control, Concept Heidelberg

May 20/22 1996, Oberstorf, Germany,
L. Huber, Development of analytical instruments with respect to customer's needs and quality standards, importance for quality and cost management of a laboratory, Second International Sonthofen Symposium: Analytical Quality and Economic Efficiency in Dairy and Food Laboratories,

June 4, 1996, Interlabor, Belp, Switzerland,
L. Huber, System Validation and System Suitability Testing, Validation '96

Sept 18/19, 1996, Stuttgart, Germany,
L. Huber, Validation of Computerized Systems, Workshop at Chromatography Symposium

Sept 25/26, 1996, Essen, Germany,
L. Huber, Validation of Computerized Systems, Moderation of a workshop at Quality Management in the Laboratory

Sept 24/27, 1996, Gemen, Germany,
L. Huber, Quality Aspects in Instrument Software, Computers in Spectroscopy

Essen, Germany, Nov 21, 1996,
L. Huber, Validating Computerized Analytical Systems, Seminar of Dr. Klinkner on 'Validation in the Analytical Laboratory', Haus der Technik,

Seoul, Bombay, Bangkok, Tokyo, Osaka, Buenos Aires, Sao Paulo, Rio de Janeiro and Littlefalls (US) from 1994 to 1997,
L. Huber, International Regulations and Quality Standards - Impact on Analytical Laboratories, Presented at Hewlett-Packard Seminars

Seoul, Bombay, Bangkok, Tokyo, Osaka, Buenos Aires, Sao Paulo, Rio de Janeiro and Littlefalls (US) from 1994 to 1997,
L. Huber, International Regulations and Quality Standards - Impact on Analytical Laboratories, Presented at Hewlett-Packard Seminars

Seoul, Bangkok, Tokyo, Osaka, and Beijing in 1994 and 1995,
L. Huber, GLP/cGMP, Validation Demands and an Instrument Vendor's Response, Presented at Hewlett-Packard Seminars

Seoul, Bangkok, Tokyo, Osaka, and Beijing in 1994 and 1995,
L. Huber, Method Validation and System Suitability Testing, Presented at Hewlett-Packard Seminars

Zagreb, Budapest and Pratislava, 1995,
L. Huber, Laboratory accreditation, Presented at Hewlett-Packard Seminars

Poster Presentations

USA; Atlanta, March 1997,
L.Huber and Mike Thomas, Validation and Qualifications of computerized systems in analytical laboratories, Poster presented at Pittcon '97

USA, Atlanta, March 1997,
A Five Step Validation Program for Food Laboratories, Poster presented at Pittcon '97

Munic, April 23/26, 1996,
L. Huber, A Five Step Validation Program for Analytical Laboratories, Poster presented at Analytica

Munic, April 23/26, 1996,
L. Huber, Quality Assurance for Analytical Instruments for Food Control Laboratories (in German), Poster presented at Analytica

Europe, London, October 21/22, 1996,
L. Huber, A Five Step Validation Program for Pharmaceutical Laboratories, Poster presented at the Pharm Analysis

Europe, London, October 21/22, 1996,
L. Huber, In-line validation as cost effective tool in pharmaceutical quality control, Poster presented at the Pharm Analysis

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Automated method validation, system suitability testing, and quality control in the routine, Pittcon

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Validation of computer systems in the pharmaceutical analytical laboratory, Pittcon

New Orleans, VA USA, March 1995,
L. Huber and M. Thomas, Validation of computer systems in the environmental laboratory, Pittcon

April 24/25, 1995, Europe, Duesseldorf, Germany,
L. Huber, Automated method validation, system suitability testing and quality control in the routine, Pharmanalysis organized by Advanstar Communications,

Innsbruck, May 29/June 1, 1995,
L. Huber and H. Godel, Validation of computerized HPLC and Capillary Electrophoresis systems, Poster presented at the HPLC 95

Innsbruck, May 29/June 1, 1995,
L. Huber and H. Godel, Automated method validation, system suitability testing, and quality control in the routine for HPLC and CE, Poster presented at the HPLC 95

s in 2002 and earlier