USP guidelines Training 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,
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.
Scope and regulatory status
Recommendations for integrated procedure lifecycle
Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics,
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.