Regulatory 101 for Medical Device and Med Tech
Navigating the FDA as an Early-Stage Company
Learn basic regulatory and quality principles in a half day event presented by Pennsylvania Bio. Member organization Regulatory and Quality Solutions (R&Q), along with other special guests – including representatives from Buchanan Ingersoll & Rooney, and Quorum, will be presenting an FDA Regulatory 101 session on Thursday, September 22. Areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance will all be explored, including a special 201 advanced regulatory section.
When:
Thursday, September 22nd
Program: 9am – 1:30pm (light breakfast and lunch provided)
Who should attend?
This event is geared towards small and start-up companies, but is also appropriate for:
Junior regulatory and quality staff
Medical device development and manufacturing staff
Seasoned regulatory and quality professionals wishing to brush up on current trends and expectations
Where:
Quorum
University City Science Center
3711 Market Street, 8th floor
Philadelphia, PA 19104
Agenda:
The agenda may change slightly between now and the date of the event, but the following topics will be covered.
8:30 – 9:00
Arrival, light breakfast/coffee, and networking
9:00 – 9:05
Program Intro from Patrick Hayakawa, Director of Member Relations, Pennsylvania Bio
9:05 – 9:30
Regulatory Overview from Maria Fagan, President, R&Q
9:35 – 10:00
Quality System Overview from John Haney, Senior Principal Advisor, R&Q
10:05 – 10:30
Design Assurance Overview from Maria Fagan, President, R&Q
10:30 – 10:45
Break and networking! Hear what your peers have to say.
10:45 – 11:10
Product Quality Overview from John Haney, Senior Principal Advisor, R&Q
11:15 – 11:40
Post-Market Overview from Theresa Miles, Director of Client Solutions, R&Q
11:45 – 12:15
Lunch and networking!
12:15 – 12:45
Spotlight: Regulatory 201 – A Deeper Dive from Carol Vierling, Senior Principal Advisor, R&Q
12:45 – 1:15
The Regulatory ABC’s for Start-up and Small Companies
1:15 – 1:30
Final Q&A (submit any questions at registration?) and Wrap Up
