The Regulation of Biological Product Manufacturing: An Introduction

Examine guidelines for establishment registration and listing. Review standards forf inspections, how to determine when a product is considered adulterated, and current Good Manufacturing practices (cGMPs). Discuss the scope of pre-license and pre-approval inspections (PAIs). Examine FDA’s inspection authority and its enforcement process.

Patrick C. Gallagher, Partner, Duane Morris LLP

This session was recorded as part of FDLI’s Virtual Introduction to Biologics  and Biosimilars Laws and Regulations Course in March/April 2020. 

 

 

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