Crossing the finish line: Preparing for and Passing a Pre-Approval Inspection

1:45 PM - 2:05 PM (PDT), Wednesday, June 15, 2022 ・ The BPI Theater

You have spent years on research and development, manufactured several process validation lots, and worked months on authoring and filing your submission.  You are ready to take your product to the commercial market, but do you and/or your manufacturing partner have what it takes to cross the finish line?  In this presentation, you will learn how to prepare for a pre-approval inspection and how to effectively manage the inspection to ensure a successful outcome.