The FDA Unique Device Identification Rule
Your office, Nov. 19, 2013
Agenda
10:00 a.m. – 10:15 a.m. |
Welcome and Introduction Dan O’Leary, President, Ombu Enterprises LLC |
10:15 a.m. – 11:00 a.m. |
FDA Spotlight Presentation: Understanding the UDI Final Rule and Its Impact on Devicemakers Attendees will learn:
Jay Crowley, Senior Advisor for Patient Safety, CDRH, FDA |
11:00 a.m. – 11:45 a.m. |
HL7 Standards for UDI Across the World: How to Ensure You Comply The good news is that there are now clearer standards for UDI submission. The challenge is understanding and implementing them. This session will provide insights on Structured Product Labeling, Common Product Models and other related HL7 standards for FDA submissions, including Individual Case Safety Reports used for eMDR, and Regulated Product Submissions used for electronic market authorization submission and approval. Compiling data on each of a devicemaker’s products will require a substantial investment in data management and SOPs that create consistent data management practices. However, if the proper SOPs and practices are not in place, databases could become confusing and sloppy. Attendees will learn:
Jackie Rae Elkin, Global Process Owner, Medtronic |
11:45 a.m. – 12:30 p.m. |
Break |
12:30 p.m. – 1:15 p.m. |
UDI in Medical Facilities — Improving Recall Management Attendees will learn:
Rosalind Parkinson, Chief Supply Chain Officer, The Ohio State University, Wexner Medical Center |
1:15 p.m. – 2:15 p.m. |
Lunch |
2:15 p.m. – 3:00 p.m. |
Practical Implementation Issues for Manufacturers Attendees will learn:
The contact person Providing the data
Dan O’Leary, President, Ombu Enterprises LLC |
3:00 p.m. – 3:45 p.m. |
Understanding What GUDID Really Is and How It Will Control Your Life for the Next Few Years Attendees will learn:
Donald Guthner, Principal, Orgenix, LLC |
3:45 p.m. – 4:00 p.m. |
Closing Remarks |