BIOT M409 — Methods in Quality Improvements, Investigations, and Audits
Examines the investigational methods used by quality assurance departments to analyze process deviations and make the decision about the severity of the deviation. Prepares students to write industry-standard Corrective Action Preventative Action (CAPA) report to conclude what corrective and preventative actions result from the investigation. Explains how a company would perform an internal audit in anticipation of an inspection by the Food and Drug Administration or an external audit for the supplier of a key raw material. Provides students the body of knowledge required for American Society for Quality’s Certified Quality Technician examination.