Risk, CAPA, and Training: An Educational Forum

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

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More Information

Contact the FDA Southwest Regional Small Business Representative or use our feedback form if you require additional information.

Disclaimer

The laws governing the FDA, FDA regulations and FDA Guidance Documents are subject to periodic change. The material in our workbooks was believed to be timely and accurate when it was developed and presented. However with the passage of time there may have been changes between what is presented here and current law, regulations, or guidance. The information provided in these workbooks does not take the place of the laws and regulations currently enforced by FDA. The workbook material does not convey any waiver of responsibility for compliance with current laws and regulations.

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Last modified: 12/03/07