Transfer According 2020 - 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
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.
Topic 1: Regulatory Requirements/Guidance on Analytical Method
Validation
• Terminology defined: qualification, validation, revalidation and verification
• FDA, EMA, ICH requirements and guidance
Speaker:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations.