Seminars - Workshops

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Attendees will get free access to a Labcompliance website with lot's of reference material. Examples include:

SOP, Examples, Checklist, 70-Page e-Book

 

 

Labcompliance offers more than 150 seminars. All seminars come with 10+ best practice documents, such as SOPs, checklists, master plans

 

Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>
With SOPs, templates and examples for easy implementationLearning from Recent
Recorded

 

FDA/ICH Compliant Development and Validation of Stability Indicating Methods
Planning - Design - Conduct - Documentation

Recorded

February 28, 2008

Practical Risk Assessment in Laboratories: Step-by-Step
With Risk Master Plan, SOPs and Case Studies for Easy Implementation

Recorded

 

Analysis of Metal Impurities According to New USP Chapters

Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities

Recorded

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025

Recorded

 

Validation of Software and Computer Systems in Analytical Laboratories

Recorded

 

Handling Out-of-Specification Tests Results and Failure Investigations

With case studies to avoid and respond to FDA 483's and warning letters

Recorded

 

Calibration and Qualification in Analytical Laboratories

With examples from planning to reporting

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

February 28, 2008

Development and Validation of Stability Indicating Methods

Sample generation - method development - validation - documentation

Recorded

 

Effective Verification of Compendial Methods (USP 1226)

Understanding USP and FDA Requirements and get Tools for Implementation

Recorded

 

System Suitability Testing for FDA and USP Compliance

With 10+ Best Practices for easy Implementation

Recorded

 

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control

Comply with the FDA and international guidances

Recorded

 

Measurement Uncertainty in Chemical Analysis
With tools to comply with ISO17025 Standard and FDA expectations
Recorded

 

Bioanalytical Method Validation 
Conduct and Document for Efficiency and FDA and EMEA compliance
Recorded

Recorded

 

Residual Solvent Analysis According to USP <467>
Understanding and implementing the revised chapter
Recorded

 

Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation

Recorded

 

Learning from Laboratory Related FDA Warning Letters

Learn from Mistakes Others Made and How You Can Avoid Them

Recorded

 

Practical Risk Assessment in Laboratories: Step-by-Step
With Risk Master Plan, SOPs and Case Studies for Easy Implementation

Recorded

 

Auditing Analytical Laboratories for FDA Compliance
Preparation - conduct - follow up - documentation

Recorded

Full-Day Workshop at the Anacon/Analytica Conference, India

 

Validation of Analytical Methods for FDA and EU Compliance

 

Dr. Ludwig Huber,

October 13, 2011, Mumbai, India

 

The workshop is dedicated to senior analysts and laboratory and QA Management of pharmaceutical development and routine laboratories and for API manufacturers. The workshop will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement most critical method validation requirements. Practical examples and interactive exercises will be dispersed into and between the presentations. About 50% of the total will be dedicated to practical sessions with life examples..

See recent similar workshop in Mumbai with Dr. Ludwig Huber

The presenter Dr. Huber just completed a compliance workshop in Mumbai. To get an impression of the interactive style of Dr. Huber's seminars and workshops click here, especially look at the photos.

What attendees will learn

  • Laboratory management, supervisors and senior analysts
  • QA managers and personnel
  •  FDA/EU, ICH, USP and ISO 17025 requirements, regulatory expectations and inspection practices
  • Understanding what questions will be asked during audits and inspection
  • How to develop a validation plan and protocol in line with regulatory and quality standard requirements
  • How to form a validation and team and understand key expectations of each member.
  • Defining the scope of methods, validation parameters and acceptance criteria
  • Prerequisites for method validation: SOP‘s, qualified instruments, qualified materials, trained analysts
  • Designing experiments for nine validation parameters
  • Defining the minimum acceptable number of variables and experiments when determining intermediate precision and reproducibility
  • Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
  • Statistical evaluation of validation results for: repeatability, intermediate precision, reproducibility, linearity, range, limit of detection, limit of quantitation, robustness and specificity
  • Going through the difference between verification and validation
  • How to transfer of analytical methods according to USP <1224>
  • Verification of standard and compendial methods according to USP <1226>
  • Recommendations what, when and how to revalidate after changes according to United States and European Pharmacopeia
  • Criteria for method adjustments vs. changes and the impact on revalidation and documentation
  • Going through seven real world method modifications with and without the need for revalidation
  • Development and validation of stability indicating methods using stress testing
  • Preparing validation reports in line with regulations and quality standards
    Going through a validation report - from beginning to end
    Going through the complete validation package for FDA submissions and inspections
  • Seven most common method validation pitfalls and how to avoid them
  • Special considerations for methods used for biological fluid analysis

Who should attend

  • Laboratory management, supervisors and senior analysts
  • QA managers and personnel
  • Regulatory affairs
  • Consultants

from

  • Pharmaceutical development
  • Pharmaceutical manufacturers
  •  API manufacturers
  • CROS doing clinical studies
  • Contract laboratories
  • Regulatory agencies
  • Laboratory suppliers of material, equipment and services

Agenda

09:30 - 10.00

Registration

10:00 - 10:15

Welcome and Introduction

10.15 - 10:30

FDA/EU, USP and ICH requirements and inspection reports

  • US FDA requirements and guidelines
  • Inspection practices - Examples of FDA Warning Letters
  • Understanding the Inspector's questions
  • USP, ICH and EU Requirements
  • Terminology: Validation, qualification and verification
10:30 – 11:30

Validation and test parameters

  • Validation parameters according to ICH Q2 and USP
  • Going through 9 ICH test parameters
  • Selecting test conditions and acceptance criteria for different sample types
  • Workshop Exercise and Q&As
11:30 - 12-00

Coffee Break

12:00 – 13:00

Iterative method development and validation

  • Preparation phase
  • Validation activities during development
  • The importance of robustness testing
  • Executing the tests
  • Workshop Exercise and Q&As
13:00 – 13.30

Documentation of test results

  • ICH and FDA requirements for documentation
  • Going through through a complete validation package
  • Validation requirements along drug development phases
  • Post-validation activities
  • Workshop Exercise and Q&As
13:30 – 14:30

Lunch Break

14.30 – 15:00

Transfer of Analytical Methods and Procedures

  • USP <1224> with 4 options for method transfer
  • Focusing on comparative testing
  • Examples for testing: FDA guidance as case study
  • Handling deviations
  • Workshop Exercise and Q&As
15:00- 15:30

Validation of Compendial Methods

  • FDA and international requirements
  • USP <1226> for method verification
  • Risk assessment as criteria for type and extend of testing
  • Examples for verification testing
  • Workshop Exercise and Q&As
15:30 - 16:00

Method Changes and revalidation

  • Method changes vs. adjustments
  • Changes that require revalidation
  • Practical recommendations from USP <621> and EP 5
  • Initiating, approving and formally releasing changes
  • Workshop Exercise and Q&As
16.00 – 16:30

Tea Break

16:30 – 17:00

Validation of Stability Indicating Methods

  • FDA and International requirements
  • Forced degradation to generate suitable samples
  • Strategies and examples for validation and testing
  • Test procedures and documentation
  • Workshop Exercise and Q&As
17:00 - 17:30

Special Considerations for methods used for body fluids

  • FDA and International requirements
  • Difference to methods used for APIs and drugs
  • Test conditions and acceptance criteria
  • Quality assurance during routine analysis
17:30 - 18:00

Final Questions and Answers - Wrap up - Prize Draw

  • Most common method validation pitfalls and how to avoid them
  • Going through most frequently asked questions
  • Final questions and answers and wrap-up
  • At the end there will a lucky draw for valuable prizes, for example for the Labcompliance Package ($599) and Labcompliance Users Club ($379)

Course registration fee

  • 2500 Rubin, including copies of all slides

Reference Material for Easy Implementation

  • 70-page e booklet written by Dr. Ludwig Huber about "Validation of Analytical Procedures"
  • SOP: Validation of Analytical Methods
  • SOP: Transfer of Analytical Procedures
  • SOP: Verification of Compendial Methods
  • Checklist: Validation of Analytical Methods
  • Example: Validation Summary Report

Course Location and Registration

Course Location: Bombay Exhibition Center, Mumbai

For registration click on

http://www.analyticaindia.com/en/Home/conference-program/Workshop

 

Or download the registration form and submit it to the Fax Number as shown on the form.

http://www.labcompliance.com/seminars/external/anacon2011/regis.pdf



About the course director

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of www.labcompliance.com, the on-line resource for validation and laboratory compliance.

  • He studied chemistry and received his PhD. from the University of Karlsruhe, Germany.  He is also the author of the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories,”. 

  • He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, PIC/S and several national health agencies. For more information, please check the website:
    http://www.ludwig-huber.com

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from an IVT conference conference with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,

 

First International GLP Award from Indian Drug Manufacturer Association

Dr. Ludwig Huber, Chief Advisor and Editor of Labcompliance, received the First International GLP award for his research and publications on GLP and GMP from the Indian Drug Manufacturer Association (IMDA). The winner has been a selected by a committee of members from the Advisory Board of IMDA

 

Dr. Ludwig Huber from Agilent Technologies received IDMA's First International GLP Award from the president Mr. Isran




Ludwig Huber presenting the key note address
All IDMA award winners together with the organization committee. Main attraction was Ludwig Huber with flowers in the middle.
Ludwig Huber donating his two validation reference books to Mr. Sipahilanami for the IDMA
Ludwig Huber has been interviewed by two journalists.

They asked him about his view on positioning of Indian Pharmaceutical industry in global market place.
Ludwig Huber celebrating this success in a fine restaurant with his favorite colleges and friends from Agilent India, Sanjev Dhar and Ganapathy Ramakrishnan (Rama, right), country manager of Agilent India