How to Write FDA-Compliant Quality Agreements | Jul 21, 2011

Did you know that you must use FDA-defined terms where they exist – it’s best for you consider them “sacred.”  In his 8th appearance in this highly praised webinar, discover a potential table of contents for your 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, and much much more.

What You Will Learn:

  • Why it is critical to have a 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
  • 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 quality agreement — conducting due diligence is critical
  • Why you need to have a contract with your suppliers on quality

Price: $399 ($50 Off With Discount Code 101250)

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Attendees will receive these free gifts:

  • Subscription to FDA Digest – 483/warning letter e-newsletter
  • Six-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

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.

Price: $399 ($50 Off With Discount Code 101250)

Click here to view more details >>

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

 

How to Write FDA-Compliant Quality Agreements
July 21, 2011, 2-3 PM EDT
Alan Minsk

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