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.

This audio conference covers:

• Why it’s important to have a compliant quality agreement
• Obligations stakeholders have under a quality agreement and who is ultimately responsible
• How to develop a quality agreement with involvement by both the sponsor and vendor
• How the relationship works between commercial and quality agreements
• How to work with vendors to develop a quality agreement – like conducting due diligence
• How to minimize inconsistencies and handle conflicts successfully

About the speaker:

Alan Minsk is a partner and practice leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. He advises pharmaceutical and medical device companies on all legal and regulatory matters relating to the FDA and DEA. He counsels, speaks and writes on a wide variety of FDA-related issues, including regulatory strategy and lifecycle management, FDA enforcement, market exclusivity, FDA inspections, corporate compliance, promotion and advertising, product liability, imports and exports, and clinical trial issues. He also conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.

Alan serves on several editorial boards, has been published in numerous professional journals, and is a frequent speaker at industry events. He earned his J.D. from Georgetown University.

Who should attend?

• Regulatory Affairs
• Legal Counsel
• Quality
• Sales and Business Development
• Marketing

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.