Full webinar recording with slide presentation and Q&A.
Date: August 31, 2018
Presenter: Gamal Amer | Ph.D., Principal, Premier Compliance Services, Inc.
In this webinar, the concepts associated with Quality Risk Management as outlined in ICH Q9 Guidance and the importance of the Risk Priority Number (RPN) are discussed. This knowledge will then be applied to decision making in prioritizing and defining the extent of qualification necessary based on the concepts advanced in the FDA’s Guidance on Process Validation of January 2011.