Top Legal and Regulatory Issues Related to Quality Agreements

Event Details

Schedule

January 20, 2011

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Location

Internet

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

Registration

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

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.