BIOT 407 - Advanced Topics in Quality Assurance and

Recent Professors: Sulatha Dwarakanath
Recent Semesters: Fall 2026
Class Size: 24 students
Credits: 4
Prerequisite: Permission of Faculty
Fall 2026 Sections: View Fall 2026 sections of BIOT 407
Transfers To: CSU
Description: Regulatory Affairs Builds upon previous knowledge of quality assurance and regulatory affairs to study the harmonized quality system approaches of ICH (International Committee on Harmonisation) Q8, Q9, Q10, and Q11. The course pays special attention to the topics of quality risk management, qualification, and validation. This course content has been aligned with the American Society for Quality's Body of Knowledge for a Certified Pharmaceutical Good Manufacturing Practice Professional examination.
Usually Held: Tue Thu 10:30am–12:20pm