Prerequisite: Open to students with a declared concentration in Regulatory Compliance, or permission
of the instructor. (First semester/3 credits)
The course is designed to provide a practical knowledge and understanding of Good
Laboratory Practice (GLP) regulations with examples useful to laboratory workers, study
directors and management. The course will address the current interpretation of the code of
federal regulations (21CFR58) and the International Committee on Harmonization (ICH).