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.