An elective course in the Certificate Programs in Clinical Trials: Medical Device and Drug Development, and Medical Product Development.
Increase your understanding of the processes of application and compliance with FDA's Good Laboratory Practice (GLP) regulations for the conduct of animal/in-vitro (non-clinical) safety studies. Learn about sponsor obligations and important considerations to evaluate a contract laboratory. Develop new insights into topics that include: the applicable regulations from the Code of Federal Regulations (CFRs), and their history, typical methods of compliance, process of GLP integration into the drug/device/biologic development process, ethics pertaining to animal care and use, applicable Quality Assurance (QA) and Quality Control (QA) processes, GLP documentation management, and the FDA's GLP Inspection program. Gain an overview of the changing scope of the GLP regulations as well as its impact on biomedical research, and the future trends.
Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 15 contact hours.