CHEM_ENG 395: Regulatory Sciences in Biotechnology (1 Unit)

Quarter Offered

Spring : MW 6:00-7:30pm ; P. Arthur Felse


The Regulatory Sciences in Biotechnology course will provide a unique educational experience at the intersection of science, engineering, and biotech regulatory compliance.


ChBE 395 will cover the following topics:

  • Federal regulations for medical product development
  • Regulatory compliance processes and organizational structure
  • Interface between biotechnology processes and regulatory sciences
  • Global harmonization of regulations
  • Regulatory documentation

The topics will be delivered as lectures, case-studies, and workshops that will be followed by a hands-on, practicum team project in biotech regulatory science.