Albert A. Ghignone
21CFR Part 58 - The Good Laboratory Practices (GLP) Regulation
FDA regulates the nonclinical safety testing of Drugs, Biologics and Medical Devices under a regulation called The Good Laboratory Practices (GLP)regulation. This webinar will address the reasoning for and the requirements of the GLP regulation. Every section of the GLP (Subparts A - Subpart K) will be addressed. FDA's "umbrella" approach to the GLP will also be discuss and FDA interpretations of the GLP reviewed.
Recorded View Anytime  Duration:90 Minutes