FDA Essential: A Strong cGMP Quality Agreement| June 24, 2019, MINSK
April 6th, 2019 // 12:30 pm @ jmpickett
In his 10th appearance in this highly praised webinar (see feedback below), discover a potential table of contents for your cGMP or GCP quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your quality agreement that meets cGMP guidelines, and much much more.
Note that Alan has given this presentation to numerous interested FDA staff in Rockville, MD. It is a topic of great interest at FDA headquarters, so it should be for you as well!
This is a GotoWebinar event. You will receive log in credentials for the webinar 24 hours before the event commences.
Feedback from recent cGMP Quality Agreement Webinar:
“Thank you very much, this Webinar was very worthwhile.” Pfizer attendee
“I found yesterday’s conference call to be useful and interesting. The topic was especially timely for us, as we have recently started focusing attention on this.” Covidien attendee
“Very useful. Thank you!” Astrazeneca attendee
“I enjoyed your presentation yesterday and found it very useful as both Quality and Supplier Agreements have become a hot topic in the global marketplace. I realize your presentation was FDA based but I believe it will help build a strong foundation for other key markets. Well done!” Boston Scientific attendee.
What You Will Learn in This cGMP Quality Agreement Webinar:
- Why it is critical to have a cGMP quality agreement — FDA may ask during an audit to review docs that describe how you manage contract service providers
- Potential table of contents for a quality agreement
- The importance of using these types of agreements for GCP contracts, such as CRO’s for clinical trial management.
- How to execute a quality agreement to designate roles/responsibilities (of sponsor/CRO) when a CRO is hosting the clinical data management system.
- Why you must use FDA defined terms where they exist – FDA’s terminology must be considered sacred
- Obligations for all stakeholders under a quality agreement — applicantion holder has ultimate responsibility for GMP compliance
- How to develop a quality agreement — quality departments of sponsor AND vendor must be involved, flexibility is key, how to work with vendor’s QA
- Relationship between the supply and quality agreement
- The relationship between a commercial and quality agreement — can be one document but quality section should be extractable
- How to work with vendors to develop a cGMP quality agreement — conducting due diligence is critical
- Why you need to have a contract with your suppliers on quality
- You also will receive a quality agreement contract sample that you can use as a basis for your own GMP quality agreement.
About the Presenter:
Alan Minsk is a Partner and Practice Leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP. Mr. Minsk advises pharmaceutical, medical device and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration and the Drug Enforcement Administration.
For companies in the pre-approval phase, Mr. Minsk counsels on clinical trial issues, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drugs, combination products, market exclusivity, premarket notifications, premarket approval applications, communications with FDA, and pre-approval discussions. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. For companies in the commercial phase, he advises on lifecycle management, post-market surveillance, Citizen Petitions, FDA enforcement and inspections, fraud and abuse compliance, promotion and advertising, product liability and interactions with FDA. In addition, he works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, co-promotions and licensing. Mr. Minsk conducts in-house training on a wide variety of FDA and fraud and abuse-related topics.
He is the General Counsel and a Board member of the PDMA Alliance, Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability.
