Basic FDA GLP Training

Good Laboratory Practice Training

Duration: 90 Minutes
Course Instructor

Bonnie M. Pappacena

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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:

  • Explain the history, intent and scope of the FDA GLPs.
  • Apply the specific requirements of the FDA GLPs and related predicate rules.
  • Recall the anticipated revisions to the FDA GLPs.
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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:

  • New Quality Assurance Auditors.
  • Quality Assurance Auditors and Managers as refresher training or as GLP skill development.
  • Quality Assurance Directors as refresher training or as GLP skill development.
  • Scientists performing GLP-regulated studies.
  • Laboratory Personnel conducting bioanalytical analyses for GCP-regulated studies.

This training is geared toward study management as well as scientific and quality professionals responsible for FDA GLP-regulated activities.

Course Instructor


Bonnie M. Pappacena

President, Qualture LLC

Bonnie M. Pappacena’s Courses


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