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BMS 544 Good Laboratory Practices: A Practical Approach

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).