Before any drug can be used on humans, it must first be proven to be safe through testing on animal models. The FDA Good Laboratory Practice (GLP) regulations were implemented in 1979 in response to the inadequate quality and scientific rigor of nonclinical (toxicology) studies. The FDA GLPs outline the requirements for conducting nonclinical studies that adhere to FDA expectations and encompass bioanalytical analyses for GCP-regulated studies. The FDA GLPs were revised in 1987 and, more recently, revisions have been proposed to refine these regulations to reflect current industry practices.
This two-hour training session is accredited and aims to provide a fundamental understanding of the FDA GLP Regulations. The lecture will cover the history, purpose, scope, and requirements of the GLPs and other associated rules. By comprehending these regulations, professionals responsible for nonclinical studies can ensure that their work is carried out in accordance with the FDA’s guidelines, leading to the protection of human subjects’ health and safety. Real-life examples and activities will be incorporated into the training to enhance the learning experience
Upon completion of this course, you will be able to:
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Basic FDA GLP training is applicable to the various industries and functions that perform nonclinical laboratory studies under FDA GLP regulations. The Basic FDA GLP Training will be valuable to all individuals working in the animal health, biologics, device, and pharmaceutical industries including:
This training is geared toward study management as well as scientific and quality professionals responsible for FDA GLP-regulated activities.
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