Good Laboratory Practices and In Vitro Toxicity Testing

micro well with colorful samples to be tested


This course covers the FDA’s current Good Laboratory Practices (cGLPs) regulations and how they affect the conduct of non-clinical laboratory safety studies, this course introduces the various elements of cGLP as described in 21 CFR 58.  Topics include, but are not limited to, a discussion of the requirements for the study director, quality assurance unit, personnel and testing facility management, testing facility operations, test and control articles, equipment, study protocol and implementation, documentation and archival of records and materials.  In addition, the history of and modern approaches to safety testing including in-vitro toxicity testing methodologies will be reviewed.


  • Recognize when cGLP protocols apply, explain their purpose and impact on laboratory work
  • Describe the history of cGLPs and the role of the FDA
  • Recognize legislation, definitions and toxicity testing in the Drug Discovery Approval process
  • Understand the FDA cGLP Regulations as defined in 21 CFR 58
  • Examine various toxicity assays used in the industrial laboratory and associated SOPs


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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 4.5 hours
  • Skill level All Levels
  • Wet Lab Yes
  • Max Students 24
  • Assessments Yes