E17-10: Lifecycle Approach to Analytical Methods Incorporating QbD Concepts into Method Development, Validation, Verification and Transfer

One-Day Course
Sunday, November 12; 8:30am – 5:00pm

Mr. Gregory Martin, Complectors Consulting, Pottstown, PA

This course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including some elements aligned with QbD concepts. By using a lifecycle approach, methods are more likely to meet their intended purpose, and scientists are more likely to have success during validation and transfer exercises.  The course will build on traditional concepts of method development, validation and transfer by introducing the Analytical Target Profile (which identifies what the method is expected to accomplish), fostering method understanding (using QbD concepts to explore the method operable region and stressing the importance of real samples in the environment where they will be tested) and demonstrating how these principles can be used iteratively as methods change location or evolve technically.  This approach will be linked with current compendial requirements and FDA guidances.  There will be opportunities for questions and discussion throughout the presentation.

Learning Objectives:
1)     Understand the lifecycle approach to method development and validation.
2)     Identify an Analytical Target Profile for Methods Being Developed
3)     Use the Analytical Target Profile to Guide Method Qualification
4)     Develop Appropriate Protocols for Method Transfer
5)     Comply with Compendial Requirements with Greater Success and Fewer Resources

Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for development, validation, verification or transfer of analytical methods, and regulatory affairs/CMC personnel responsible for filings involving analytical methods.

1. Introduction: Using a Lifecycle Approach for Analytical Procedures
2. Method Design: Introducing the concept of the Analytical Target Profile
     * Practical Exercise: Developing an ATP
3. Method Development Using the ATP as a Tool
* Assay or uniformity
* Dissolution
* Stability indicating methods
* Practical Exercise:  Approach to developing a stability indicating method
4. Method Validation: Applying the concepts of ICH Q2 and USP <1225>
* Rationale for demonstrating the validity of an analytical method 
    * Life cycle approach to method validation 
    * Design of validation experiments  
    * Practical Exercise:  Designing a validation protocol 
5. Method Modifications: Change Control and Method Revalidation Strategies
6. Verification of Compendial Procedures 
7. Method Transfer 
8. Troubleshooting Analytical Methods 
9. Questions and Discussion

Mr. Greg Martin is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.  In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.  He is also Past Chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.  Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.