In the Know

Quality Management Systems & The Future of MDSAP
Speaking Engagements
October 24, 2017
Atlanta, Georgia

Building Quality (Agreement) into Your Product

On October 24, 2017, Michael Burke and Elizabeth Mulkey will speak at the Georgia Bio Summit on the topic, "Quality Management Systems & the Future of MDSAP."

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. Counsel and RA/QA personnel should be aware of the agency’s current thinking.

Topics for Discussion

  • Review the FDA guidance document and better understand agency expectations
  • Explore common areas of potential dispute between contract manufacturers and the sponsoring companies and practical tips to address these issues
  • Evaluate ways to minimize regulatory risk and business conflicts

For more information, please click here.