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, accuracy and precision of such methods.
Faculty Response The answer is yes because they have expertise necessary to ensure that the system they have designed, provided and delivered to you is operating in accordance with user specifications.
The importance of analytical procedures
ICH Q12
Introduction to lifecycle management of analytical methods
USP approach for method validation: in-process revisions to Chapters 1200, 1210 and 1225
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.