Curriculum / DescriptionsCHEM_ENG 395: Regulatory Sciences in Biotechnology (1 Unit)
Curriculum
/ Descriptions
Quarter Offered
Description
The Regulatory Sciences in Biotechnology course will provide a unique educational experience at the intersection of science, engineering, and biotech regulatory compliance.
Topics
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.
