F Quality and Regulatory Compliance in the Biosciences

Catalog description

36 hours lecture per term. This course will cover quality assurance and regulatory compliance for the bioscience industries. Topics will span quality control and Federal 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 CGMP (Good Manufacturing Practices), ISO9000 (International Standards Organization), Six Sigma and Lean. (Degree Credit) (CSU)