Ccourse, designed for those with knowledge of medical device manufacturing, starts with one full day of review of ISO 13485:2003. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements. In addition, the concepts of ISO 14971:2007, “Application of Risk Management to Medical Devices,” are introduced. Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing. Students also learn how to apply the guidance of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing,” to implement effective internal audit programs for medical device manufacturing organizations. (2.4 CEUs)
08SI24000 Sep 15 – 17 (M-W, 8am–5:30pm)
$1195
Continuing Education Center | 1100 South Marietta Parkway, Building #WE | Marietta, GA | 30060 | 678-915-7240