Units: 4
Prerequisites: BTEC 120.
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 builds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of the International Council for Harmonisation Q8 through Q11. The course pays special attention to the topics of quality risk management, qualification, and validation. This course is open only to students enrolled in the biomanufacturing bachelor's degree program.