Quality Agreements & FDA – What You Must Know to Comply
Staying abreast of ever changing regulatory requirements with the FDA is not easy. Recent guidance from FDA relating to contract manufacturing has emphasized the importance of Quality Agreements and how FDA views them. Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements. Join our interactive online training course where you will learn:
- Current FDA enforcement priorities and how to avoid pitfalls that cost money, time and goodwill
- Why good Quality Agreements are as essential as good Supply Agreements
- Why you should have a stand-alone Quality Agreement rather than combining it with a Supply Agreement
- Why FDA will likely request to see your Quality Agreement during an inspection, and what you should do
This course will be of benefit to anyone involved in Good Manufacturing Practice and Quality regulations on a global or domestic scale. Additionally, those who are responsible for the drafting and/or implementation of quality agreements or concerned with regulatory compliance issues will find this course to be extremely useful.
Nathan A. Beaver is a partner with Foley & Lardner LLP and is a member of the firm’s Government & Public Policy and FDA Practices, and the Food & Beverage Industry and Life Sciences Industry Teams.
Mr. Beaver’s practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval process and patent and exclusivity issues related to the Hatch-Waxman Act.
Mr. Beaver was named a 2012 BTI Client Service All-Star, one of only 272 attorneys so honored throughout the United States. He is a frequent speaker at the Food and Drug Law Institute events and the author or co-author of a number of regulatory and compliance articles focusing on FDA.