Tricia Kaufman to Present on Quality Systems Regulations at FDA Boot Camp
Stinson Leonard Street attorney Tricia Kaufman will present at the American Conference Institute's FDA Boot Camp Devices Edition July 26-28, 2017 at the Wyndham Grand Chicago Riverfront in Chicago.
Tricia is presenting at 9:30 a.m. July 28 with Brian Malkin, an attorney at Arent Fox in Washington, DC. Their presentation is "Quality Systems Regulation and UDI."
The conference will deliver an in-depth coverage of FDA regulatory law to professionals who work in conjunction with the medical device industry—such as products liability specialists, in-house counsel, business development executives, and compliance professionals. Faculty will share knowledge on many topics including:
- The organization, jurisdiction, functions, and operations of FDA
- An overview of medical device regulations and classification
- Clinical trials and IDEs
- The 510(k), PMA, and de novo pathways and choosing the right one
- Device labeling, promotion, and related First Amendment concerns
- General post-market controls and MDRs
- Quality Systems Regulation and UDI
- Understanding FDA’s Enforcement authority and how to remain compliant
- Recalls and Withdrawals
For more information on the conference, or to register, visit the ACI's website.