Recorded March 11, 2021 | On-Demand Webinar
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.
his session was recorded as part of FDLI’s virtual Introduction to Biologics and Biosimilars Law and Regulation course in March 2021.