BTEC 3400 - Quality Assurance and Regulatory Issues in Biotechnology

3 Credit Hours 3 Class Hours 0 Laboratory Hours
Prerequisites C or better grade in BTEC 3301.
This course gives an overview of regulatory issues and practices in biotechnology industries, focusing on the requirements of the FDA and USDA. It covers regulatory systems, including Current Good Manufacturing Practice (CGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Hazard Analysis Critical Control Points (HACCP). Other topics include record keeping, standard operating procedures, methods validation, statistical methods, compliance, and enforcement.