ABT 740 Regulatory Practice and Compliance

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

ABT 740 course syllabus

Semesters Offered: Fall 2022

Credits: 3

Degree Level: Master's

Course Track: Quality Assurance and Compliance Track