Device Supplier Controls
Device Supplier Controls:
Does the FDA’s Next 483
Have Your Name on It?
Your office, Feb. 26, 2014
Agenda
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference |
10:15 a.m. – 11:05 a.m. |
Opening Keynote: Supplier Controls — FDA Medical Device Requirements Attendees will learn:
M. Isabel Tejero, MD PhD, Acting Lead, Quality Systems Working Group, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA |
11:05 a.m. – 11:55 a.m. |
Legal and Regulatory Issues to Consider Relating to Quality Agreements:
Why it is Important to Have a Strong Quality Agreement Attendees will learn:
Alan Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP |
11:55 a.m. – 12:10 p.m. |
Break |
12:10 p.m. – 1:00 p.m. |
Recent FDA Supplier Control Inspection and Enforcement Trends Attendees will learn how to:
John Avellanet, Principal Consultant, Cerulean Associates |
1:00 p.m. – 2:00 p.m. |
Lunch |
2:00 p.m. – 2:50 p.m. |
Assessment Tool for Choosing the Right Subcontractor or Supplier Attendees will:
Jackie Torfin, Vice President of Quality, Heraeus Medical Components |
2:50 p.m. – 3:40 p.m. |
Lessons from Veteran Supplier Manager: Understanding How to Manage Suppliers Whether You’re a Big or Small Company Attendees will learn:
David Parkin, Supplier Development Manager, Boston Scientific |
3:40 p.m. – 4:00 p.m. |
Closing Comments and Adjournment |