Guidance Training 2021 - Analytical Method Validation and Transfer According to the New FDA Guidance Training

This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis
This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers, covering in-process, release and stability assays commonly used by QC.
Terminology defined: qualification, validation, revalidation and verification
FDA, EMA, ICH requirements and guidance
Validation lifecycle for analytical methods
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.