GMP/GLP and Writing SOPs

Catalog description

This course gives an introduction to the concepts of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and their applications in the biotechnological manufacturing of therapeutic products. The course will cover the concepts of GMP and GLP; the history of GMP/GLP; federal and international regulation for GMP/GLP; and how GMP/GLP are being applied in a bio-manufacturing facility. Writing of Standard Operating Procedures (SOPs) is included as part of the GMP curriculum. Students will learn to read, review, and write an SOP.