342554 Life Post Approval: A Real Life Example

Thursday, November 7, 2013: 12:30 PM
Plaza B (Hilton)
Christine Seymour, Pfizer Global Research & Development, Pfizer Inc, Groton, CT

Quality by Design poses challenges and opportunities post NDA and MAA approval.  This presentation will explore post approval Quality by Design challenges and opportunities.  Case studies will be presented that highlight the recent learnings and challenges in the post approval area from the technical perspective as well as the regulatory perspective.

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See more of this Session: Pharmaceutical Manufacturing Post Launch: Process Improvements and Process Learning
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum