Recent SemestersFall 2026, Fall 2025, Fall 2024Class Size24 studentsCredits4PrerequisiteSTAT C1000 or STAT C1000H or equivalent, BIOL M02A or BIOL M02AH , BIOT M10 or BIOL M13 , BIOT M02C or BIOL M12C , BIOT M02D or BIOL M12D , and BIOT M02E or BIOL M12E Transfers ToCSUDescriptionBuilds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of the International Committee on Harmonisation (ICH). Pays special attention to the topics of quality risk management, qualification, and validation. Covers topics in the American Society for Quality’s Body of Knowledge for a Certified Pharmaceutical Good Manufacturing Practice Professional examination.Usually HeldTue Thu 9:00am–10:50am, Mon Wed 9:00am–10:50am 