Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse biotechnology industry, both domestically and internationally. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with agencies and to submit required documentation for successful product development.
Prerequisites: ABT 700, ABT 705, ABT 710
Semesters Offered: Fall 2023, Fall 2024
Degree Level: Master's
Course Track: Quality Assurance and Compliance Track