BTEC 3400 - Drugs, Biologics, Devices and Diagnostics: Conception to Regulatory Approval

3 Class Hours 0 Laboratory Hours 3 Credit Hours
Prerequisite: Grade of “C” or better in BIOL 3300 or CHEM 3361/3361L; or approval of Biology/Physics Department Chair.
Students will be given an overview of regulatory issues and practices in biotechnology, focusing on the requirements of the FDA and USDA. Current Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice and Hazard Analysis Critical Control Points will be discussed as applied to the conception through approval of drugs, biologics and medical devices. Students will demonstrate an understanding of procedures involved in clinical trials including record keeping, standard operating procedures, methods validation, compliance, and enforcement.