Federal Register Notice: FDA’s Dallas District Office, in collaboration with the FDA Medical Device Industry Coalition will hold a public workshop 4/28/06 entitled "Risk Management, Corrective and Preventive Actions, and Training: An Educational Forum." The workshop is intended to provide information about FDA's medical device quality systems regulation to regulated industry, particularly small businesses. It will be held from 8 a.m. to 5 p.m. at The Westin City Center, 650 North Pearl St., Dallas, TX. The following topics will be discussed: (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, and (6) training program effectiveness. Contact David Arvelo or Cassandra Davis, (214) 253-4952 or (214) 253-4951. To view this notice, click here.