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.

Neil Di Spirito, Partner, Brown Rudnick 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 March 2022. 

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