The Silent Killer: How A Poor Quality System Could Adversely Impact Your Business. An Overview of Hot Issues in Pharmaceutical Manufacturing and Supply Chain

We all know the importance and criticality of ensuring that all parties involved in manufacturing of products regulated by the FDA, including drug products, comply with current good manufacturing practices. The backbone of compliance begins with a robust quality management system, and the landscape of manufacturing compliance, including adhering to FDA standards and similar standards worldwide, is a complex matter and requires an understanding of the area as well as deployment of proactive strategies and approaches. Join our panel of experts as we explore a compliance framework associated with manufacturing and supply operations including QMS, and some of the latest enforcement concerns and disruptions.

Presented by Veleka Peeples-Dyer, Partner at Baker McKenzie, Sabrina Mays-Diagne, J.D., is Associate General Counsel at Otsuka America Pharmaceutical, Inc., and Samantha Wilson Jones, Associate General Counsel at Spark Therapeutics, Inc.

Join us after the panel discussion for networking and breakouts. 

Agenda:
12:30-1:30 - Panel discussion
1:30-2:00 - Networking and Breakouts


(This session is for informational purposes only, no VA MCLE will be provided.)