(WINTER 2010)

An elective course in the Certificate Programs in Clinical Trials: Medical Device and Drug Development, and Medical Product Development.
Gain the knowledge to understand and comply with FDA Good Laboratory Practice (GLP) regulations for the conduct of animal/in vitro safety studies. Enhance your understanding of topics including: regulations from the Code of Federal Regulations (CFRs), European and Japanese regulations, typical methods of compliance, how GLP fits into the drug/device/biologic development process, and ethics regarding animal care. Learn about sponsor obligations and how to evaluate a contract laboratory. Visit a clinical research center to reinforce the importance of GLP guidelines and compliance. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 15 contact hours. See enrollment confirmation for login information.

Frank Zaldivar, Ph.D., director, Pediatric Cytokine/General Clinical Research Center Laboratories, College of Medicine, UC Irvine, has over 15 year's experience in private, government and university research laboratories. In addition to many years of experience in a broad range of laboratory techniques in clinical research studies, he has extensive experience in the implementation of the Code of Federal Regulations (CFRs) and the Code California Regulations (CCRs). Dr. Zaldivar is widely published in peer reviewed scientific journals.