Focuses on the importance of quality control and validation in biotechnology product design, development, and manufacturing. Explores quality systems and documentation, global quality standards, and methods for assessing validation including installation, operational, and performance qualifications. Overviews bio-manufacturing processes, automation, and cGLP/cGMP practices necessary to meet quality standards.
Prerequisites: ABT 700, ABT 705, ABT 710
Semesters Offered: Fall 2023
Degree Level: Master's
Course Track: Quality Assurance and Compliance Track