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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 risk
Incorporating risk management throughout the product lifecycle |
Dr. William Hyman, Professor, Biomedical Engineering, Texas A&M University
Ms. Lori Holder, Alcon Labs
Ms. 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 program
Training effectiveness |
Ms. Rebecca Rickey, Vice
President, Quality Assurance, Sterigenics International
Dr. 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.
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