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

Presentations in 2008

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
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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, KL
July 14 and July 16, KualaLLumpur -Malaysia 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

Audio Seminars