BIOTECH410 - Methods in Quality, Improvements, Investigations, and Audits

This course examines investigational methods used by quality assurance departments to analyze process deviations and make decisions about severity of deviation. Students learn to write industry-standard corrective and preventive action (CAPA) reports to conclude what corrective and preventive actions result from the investigation. The course also covers how a company would perform an audit in anticipation of an inspection by the Food and Drug Administration or for the supplier of a key raw material. The course is designed in accordance with the American Society's Body of Knowledge to adequately prepare students for the Certified Quality Technician examination. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.