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.