Recent ProfessorsNot yet assignedRecent SemestersNo scheduled sections on recordClass SizeNot publishedCredits4PrerequisiteAdmission into the Biomanufacturing Baccalaureate Transfers ToCSUDescriptionand Audits program; Permission of faculty; BIOT 407 Examines the investigational methods used by quality assurance departments to analyze process deviations and make the decision about the severity of the deviation. In this course students learn to write industry-standard CAPA (Corrective Action Preventative Action) report to conclude what corrective and preventative actions result from the investigation. The course also covers 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. This course content has been aligned with the American Society for Quality's Body of Knowledge for a Certified Quality Technician examination. 