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.

Patrick C. Gallagher, Partner, Duane Morris LLP

This session was recorded as part of FDLI’s Virtual Introduction to Biologics  and Biosimilars Laws and Regulations Course in March/April 2020. 



Get Access

  • +$100 for nonmembers

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.


On-demand content can be played back on most devices.

If you have concerns, please click the Test Your System link to determine your device's compatibility, as well as system requirements. 

CLE credit is not currently available for pre-recorded sessions.

Related Content