Top Legal and Regulatory Issues Related to Quality Agreements

Event Details


January 20, 2011

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Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team, explain the do’s and don’ts of writing quality agreements, with a focus on both drugs and medical devices.· 

 This 90-minute webinar will address such issues as: 

  • Why it is critical to have a quality agreement — FDA may ask during an audit to review documents that describe how you manage contract service providers
  • Obligations for all stakeholders under a quality agreement — application holder has ultimate responsibility for GMP/GCP compliance
  • How to develop a quality agreement — quality departments of sponsor AND vendor must be involved
  • The relationship between commercial and quality agreements — 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
  • How to minimize inconsistencies and conflicts


  • CLE credit has been applied for. 
  • If you have any questions regarding this topic, please contact Alan Minsk at  Please direct all other questions to Tracey Chapman, Event Coordinator at

We are excited to announce this webinar is a 3-part series that will include additional speakers from the Food and Drug Team. Please continue to visit our website for more information.