Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
(PL Tittle) Lifecycle Approach to Analytical Methods for Drug Products”
Introduction: Using a Lifecycle Approach for Analytical Procedures
Introducing the Concept of the Analytical Target Profile
Method Design and Development Using the ATP as a Tool
Method Performance Qualification
Continued Procedure Performance Verification
Changes: Method Modifications, Method Transfer, Verification of Compendial Procedures
Questions and Discussion
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including 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 of Risk Assessment and Control Strategy, 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.
Chemists, supervisors, managers or directors from pharmaceutical (human and veterinary), generic or OTC companies or contract research organizations who are responsible for
Gregory Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. 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. 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.
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