The pharmaceutical industry is tightly regulated, allowing the commercial sale of medicinal products only if regulatory requirements are met. This course emphasizes the US FDA GXPs that apply to managing quality within the pharmaceutical, chemical, and biotechnology industries and touches on differences between the other regional markets in the rest of the world. Students will gain an introduction to Good Practices (or GxPs) including Manufacturing (GMPs), Clinical (GCPs), Laboratory (GLPs), and Automated Manufacturing (GAMPs), and will explore the lifecycle of a drug, from development through to commercial production.
Course Number: BIOL-40353
Credit: 3.00 unit(s)
Related Certificate Programs: Quality Assurance and Control
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or unex-sciencetech@ucsd.edu for information about when this course will be offered again.