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.
Christina M. Markus, Partner, King & Spalding LLP
This session was recorded as part of FDLI’s Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in October 2021.