Course Description: 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. This course is one of four in the Medical Device Manufacturing Processes and Practices Certificate program. Upon successful completion of the certificate, students will qualify for entry-level positions, including Quality Technician, Quality Inspector, and Quality Assurance Inspector.