Complaint Handling Violations for Device Companies Agenda
Complaint Handling Violations for Device Companies
The #1 Warning Letter
An FDAnews Virtual Conference
Thursday, March 28, 2013 • 10:00 a.m. – 4:00 p.m. EDT
10:00 a.m. – 10:15 a.m. |
Welcome |
10:15 a.m. – 11:15 a.m. |
We’re with the FDA and We’d Like to Start with Your Complaint Files — How Does the FDA Review Complaint Files? Rita Hoffman, Managing Partner, Regs & Recall Strategies, LLC |
11:15 a.m. – 11:30 a.m. |
Break |
11:30 a.m. – 12:30 p.m. |
10 Things I Learned the Hard Way Regarding Complaint Management — An In-the-Trenches, War Story Documentary of What Can Go Wrong and How to Fix It Matts Bell, Business Development Manager, Argos Global |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:30 p.m. |
Remediation? Now? Are You kidding? How To Tackle A Medical Device Complaint Remediation Project When You're Buried In Complaints Joaquin Kurz, Director, Quality Assurance, CircuLite Inc. |
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
Promises and Pitfalls: The Art of Preparing and Implementing eMDR Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Software |
3:45 p.m. – 4:00 p.m. |
Closing Remarks |