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.
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.