The Regulation of Biological Product Manufacturing: An Introduction

Examine requirements for establishment registration and listing. Learn about inspection requirements. Recognize FDA’s inspection authority and its enforcement process.

Seth Olson, Associate, Latham & Watkins LLP

This session was recorded as part of FDLI’s Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. 

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