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
Whether involved in method development, method validation, method verification or method transfer, this course will provide a broad understanding and “hands-on” knowledge of the method validation process and the difficulties encountered
• 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.