Agenda
Risk Management Through Product Life Cycle: An Educational Forum held in Arlington, Texas, on April 2, 2010.
| 7:30 – 8:00 | Continental breakfast and registrant sign-in | ||
| 8:00 – 8:10 | Opening remarks |
Reynaldo (Ricky) Rodriguez, FDA Dallas District Director | |
| 8:10 – 8:40 | The Role of Management in Using Risk Assessments |
Joseph (Joe) Tartal, Technical Branch Chief at FDA CDRH DSMICA | |
| 8:40 – 9:30 | ISO 14971: Overview of the Standard |
William (Bill) Hyman, Sc.D., Professor of Biomedical Engineering at Texas A&M University | |
| 9:30 – 9:45 | Break (refreshments provided) | ||
| 9:45 – 10:15 | Risk Management in Design: An FDA Perspective |
Ricki Chase, Supervisory Investigator, FDA Denver District Office, Salt Lake City Resident Post | |
| 10:15 – 11:30 | Risk Management in Design: Industry Solutions |
Julie Thomas, Director of Quality, LabNow | |
| 11:30 – 11:45 | Q&A Panel | ||
| 11:45 – 12:45 | Lunch (buffet provided) | ||
| 12:45 – 1:15 | Risk Management After Design: Production and Process Controls |
Bonnie Pierson, Investigator, FDA Kansas City District Office | |
| 1:15 – 2:00 | Risk Management as a driver for Supplier Controls |
Cindy Walters, Quality Manager, Boston Scientific | |
| 2:00 – 2:15 | Break (refreshments provided) | ||
| 2:15 – 3:00 | Risk Management & Postmarket Surveillance |
Albert (Al) Alonso, VP Quality Assurance, Clinical/Regulatory Affairs, DJO Surgical | |
| 3:00 – 3:30 | FDA, Risk Assessment and Post Market Surveillance |
Regina Barrell, Senior Case Review Expert, FDA Office of Enforcement, Division of Compliance Management and Operations | |
| 3:30 – 4:00 | Q&A Panel | ||
| 4:00 – 5:00 | Tour of Cowboys Stadium (included, requires sign-in) | ||
Disclaimers
The information provided in handouts herein does not take the place of the laws and regulations enforced by FDA.
Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, HHS, FDA or any of its components.
FDA is not responsible for the contents of any outside information referenced in the handouts herein.
The information in the handouts herein was believed to be correct at the time it was developed. However laws and regulations are subject to change. Always check for the most current information before proceeding on the basis of the information contained herein.
The handouts herein do not convey any waiver of responsibility to the firm, nor impart any immunity to the firm for violations that may occur, even if you implement our recommendations as per 21 CFR 10.85(k).
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