BioOhio and Leadership Member Regulatory and Quality Solutions (R&Q) are excited to present an ongoing series of medical device “FDA Regulatory 101” events.
These sessions will cover a variety of regulatory topics such as FDA warning letter response, risk management, usability engineering, as well as a broad overview of medical device regulation in the US, Canada, and the European Union.
Each session of the FDA Regulatory 101 Series will cover a spotlight topic along with basic regulatory and quality principles. This cost-effective series is geared toward small and start-up companies, junior regulatory and quality staff, medical device development and manufacturing staff, or even seasoned regulatory and quality professionals wishing to brush up on current trends and expectations.
Agenda
1:30 – 2:00: Regulatory Overview
2:00 – 2:30: Quality Systems Overview
2:30 – 3:00: Design Assurance Overview
3:00 – 3:30: Product Quality Overview
3:30 – 3:45: Coffee Break
3:45 – 4:15: Post-Market Overview
4:15 – 4:45: Spotlight Topic: Combination Products
4:45 – 5:30: Q&A and Networking
Speakers
- Nancy Morrison, Director of Regulatory Affairs, R&Q
- Steve Keverline, Director, Ohio Operations, R&Q
- Jake O’Donnell (Former FDA), Senior FDA Compliance Principal, R&Q
