Analytical Methods 2021 - Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines Training

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the pharmaceutical industry to have procedures in place to ensure suitable levels of reliability,
Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP.
Introduction to lifecycle management of analytical methods
USP approach for method validation: in-process revisions to Chapters 1200, 1210 and 1225
Learnings from the new FDA, WHO and PDA method validation guidelines
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.