Units: 4
Prerequisites: BTEC 330 and BTEC 340.
Enrollment Limitation: Only open to students enrolled in the bachelor's degree program in biomanufacturing at MiraCosta College.
Lecture 4 hours.
Course Typically Offered: Spring

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. Course content is aligned with the American Society for Quality's Body of Knowledge for a Certified Quality Technician examination. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.