When it comes to making a quality product, it is advisable, if not expected, that companies will enter into agreements with third-party companies. The FDA has issued guidance on the value of quality agreements between contract manufacturers and companies. The guidance also outlines the agency’s expectations on what should be included in such an agreement. In addition, FDA has issued enforcement actions in the quality agreement area. Counsel and RA/QA personnel should be aware of the agency’s current thinking.
Register now for this one-hour complimentary webinar with AGG Partners Michael E. Burke and Alan G. Minsk as they discuss:
- Review the FDA guidance document and better understand agency expectations
- Explore common areas of potential dispute between contract manufacturers and the sponsoring companies, including practical tips to address these issues
- Evaluate ways to minimize regulatory risk and business conflicts
There will be an opportunity for Q&A following the presentation.
Credits: This webinar is pending CLE credit by the State Bar of Georgia.