This 24-hour course meets one day a week for 3 hours, over 8 weeks. This course introduces the quality system governing the life science industry with emphasis on those that impact medical device development and manufacturing. A thorough understanding of 21 CFR 820 subparts, an overview of ISO 13485 and quality management system audits will be covered. As a result of this training students will be able to evaluate non-compliance quality systems issues and their possible undesirable consequences; explain the benefits of audits at a medical device company; compare the key differences between 21 CFR820 vs ISO 13485; analyze documents for conformity to good documentation practices (GDP); and explain the purpose of controls including design, purchasing, production, distribution, and process controls.