Course Description: This 18-hour course meets one day a week for 3 hours over 6 weeks. This course is an introduction to the field of auditing concepts. Students will gain basic foundational knowledge to quality auditing in the medical device industry. This course will explore standards and regulations from an auditor's perspective. As a result of this course students will be able to describe principles of quality auditing, including types of quality audits, approaches, management components, and documentation; compare major differences of Food & Drug Admin (FDA), International Standards Org (ISO), and Global Harmonization Task Force (GHTF) in governing medical device manufacturing; apply Good Documentation Practices (GDP); and describe Corrective and Preventative Actions (CAPA) in medical device manufacturing. This course is not one of the required courses for the Medical Device Processes and Practices Certificate Program. This is a standalone course.