Agenda

Here is the agenda for the FMDIC Risk, CAPA, and Training Educational Forum.

8:00 AM	Registration and continental breakfast
8:30	Welcome	Mr. David Glasgow, Director, Investigations Branch, Dallas District Office, US Food and Drug Administration
8:45	RISK MANAGEMENT:Overview of EN 14971 and residual riskIncorporating risk management throughout the product lifecycle	Dr. William Hyman, Professor, Biomedical Engineering, Texas A&M UniversityMs. Lori Holder, Alcon LabsMs. Monica Wilkins, National Expert, US Food and Drug Administration
10:45	Break
11:00	CAPA Part 1:Overview of a closed-loop CAPA system	Ms. Monica Wilkins, National Expert, US Food and Drug Administration
12:00 PM	Lunch, provided
1:00	CAPA Part 2:CAPA effectiveness	Mr. Phil Ralston, Medical Device Manufacturers Association
2:00	Break
2:15	TRAINING:Overview of a training programTraining effectiveness	Ms. Rebecca Rickey, Vice President, Quality Assurance, Sterigenics InternationalDr. Philip Steele, Consumer Safety Officer, Dallas District Office, US Food and Drug Administration
4:00	Break
4:15	Q&A panel	Mr. David Arvelo (moderator), Small Business Representative, Southwest Regional Office, US Food and Drug Administration

Continuing Education Units

Texas A&M University (TAMU) offered Continuing Education Units (CEU) to those in attendance who requested it on the day of the event.