Risk, CAPA, and Training: An Educational Forum

The Westin City Center 650 North Pearl StreetDallas, Texas

8:00 AM – 5:00 PM, Friday, April 28, 2006 Add to Outlook Calendar

Co-sponsored by the Food and Drug Administration, Office of Regulatory Affairs, Southwest Region, Dallas District Office, in collaboration with FMDIC, this public workshop is intended to provide information about FDA’s medical device quality systems regulation (QSR) to regulated industry, particularly small businesses.

The goal of the workshop is to present information that will enable manufacturers and regulated industry to better comply with the medical device QSR. The following topics will be discussed at the workshop:

1. Overview of the International Organization for Standardization (ISO) standard EN 14971, and residual risk
2. Incorporating risk management throughout the product lifecycle
3. Overview of a closed-loop corrective and preventive action (CAPA) system
4. CAPA effectiveness
5. Overview of a training program
6. Training program effectiveness

• Agenda
• Speakers
• Reading

More Information

• Federal Register Notice of Public Workshop: December 7, 2005 (Volume 70, Number 234) Pages 72844-72845 [HTML] [PDF]
• Contact the FDA Southwest Regional Small Business Representative or use our feedback form if you require additional information.

denotes a file in Portable Document Format (PDF). You will need Adobe Acrobat Reader to view and print these documents. Download it free from Adobe.com.