Thursday, December 1, 2011

Developing Effective Quality Agreements: Legal and Regulatory Issues

ia being presented by Alan Minsk, Partner, with Arnall Golden Gregory LLP and airs on Wednesday, December 14th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Supplier control has become a major focus area for FDA in recent years, and as such, an area which is seeing heightened enforcement efforts. This represents a significant challenge for medical device and pharmaceutical companies, who need to respond accordingly to ensure their supplier quality agreements will pass muster with FDA. The landscape is changing quickly, and those without the critical regulatory information will be ill-prepared for FDA scrutiny.

In this audio conference presentation, Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team at Arnall Golden Gregory LLP, guides attendees through the critical points and the pitfalls to avoid when drafting quality agreements. The presentation addresses the vital legal and regulatory issues affecting pharmaceutical and medical device manufacturers, leaving attendees better prepared to meet customer and FDA expectations regarding supplier quality.