BIOT 2441 - Quality Assurance for Biosciences

This course provides and introduction to Good Laboratory Practice (GLP) Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) as well as a comprehensive coverage of all steps involved with the regulatory approval process for biotechnology-derived products. Preparation for clinical studies, facilities inspection and scientific and regulatory principles will be covered as well as a discussion of when, where, and how the Food and Drug Administration (FDA) plays a role in these processes. Additionally, students will learn the rationale for writing standard operating procedures (SOP) in a biotechnology environment. The course will cover the procedures, formats, and writing styles used in writing, implementing, and evaluating SOPs.

Location: L
Credits: 3
Classroom Lecture Hours: 45
Prerequisite(s): BIOT 1400