MBIOTECH 482: Regulatory Sciences in Biotechnology

Quarter Offered

Winter ; P. Arthur Felse


(Basic Biology and Chemistry)


The Regulatory Sciences in Biotechnology course will provide a unique educational experience at the intersection of science, engineering, and biotech regulatory compliance. Topics such as federal regulations for drug product development, regulatory compliance processes and organizational structure, interface between biotechnology processes and regulatory sciences, global harmonization of regulations, and regulatory documentation will be covered in this course. One part of this course will be delivered as lectures, case-studies, and workshops, and the other will be delivered as a hands-on, practicum team project in biotech regulatory science. Grading will be based on project-based homework, project reports, and project interviews.

Crosslisted as CHEM_ENG 382.