BIOL 78 - Quality and Regulatory Compliance in the Biosciences

2 units
2 hours lecture
Prerequisite: None
Corequisite: None
Enrollment Limitation: None
Recommended Preparation: None
Credit, degree applicable
Transfer CSU

This course will cover quality assurance and regulatory compliance for the bioscience industries. Topics will span quality control and Food Drug Administration (FDA) regulations for the biotechnology, biopharmaceutical, biomedical device, and food industries. Theories and application of quality assurance and quality control will be presented and several different quality systems will be discussed such as GMP (good manufacturing practices), ISO9000 (International Standards Organization), Six Sigma, and Lean.