The following is the agenda for the Educational Forum on Medical Device Reporting, Complaints, and Recalls, Corrections, and Removals, including the presentations and speaker bios.

Timeframe Topic Speaker
7:30 -8:00 Registration and continental breakfast Committee and volunteers
8:00- 8:10 Opening Remarks Ricky Rodriguez (FDA)
8:10 – 8:55 Complaints and Complaint Investigations Graham Giesen (FDA)
8:55 – 9:40 Complaint System Al Alonso (Industry)
9:40 – 10:00 Break (refreshments provided)
10:00 – 10:45 Medical Device Reporting Jeff Wooley (FDA)
10:45 – 11:30 MDR: Failures, Successes and Solutions Scott Eden (Industry)
11:30 – 12:00 Q & A panel Cadre
12:00 – 1:00 Lunch buffet
1:00 – 1:45 Corrective and Preventive Action – Background and Examples Kimberly Lewandowski-Walker (FDA)
1:45 – 2:15 Root Cause Analysis Dr. John C. Criscione (Academia)
2:15 – 2:30 Break (refreshments provided)
2:30 – 3:15 Corrections and Removals 21 CFR Part 806 Kimberly Lewandowski-Walker (FDA)
3:15 – 4:30 Dealing with 483’s, Warning Letters, and Other Enforcement Actions David Furr (Industry)
4:30 – 5:00 Q & A panel Cadre

The presentation files above are in Portable Document Format (PDF). If your computer does not have a PDF reader, you may wish to install the Adobe Acrobat Reader, a free download.