GLP: Good Laboratory Practice Overview

This course introduces the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP).  The course will help prepare learners to establish and document a system of GLP controls required to test medical products where data are intended for inclusion in a regulatory filing in the United States, the European Union, Japan, and many other parts of the world.

After completing this course, participants should be able to:

  • List the purpose of Good Laboratory Practice (GLP) regulations
  • Describe two events that inform the institution of the GLP regulations
  • Describe four elements of GLP
  • Discuss the three areas that will be reviewed during a GLP inspection
  • List the responsibilities of management
  • Understand personnel responsibilities
  • Describe the responsibilities of the study director
  • Discuss the responsibilities of Quality Assurance
  • Understand the GLP area of Facilities and Instrumentation
  • Describe standard operating procedures
  • Discuss the GLP area of Reagents and Solutions
  • Understand the GLP area of Animal Care
  • Describe the GLP area of Test and Control Materials
  • Describe the purpose of SOPs and document change control
  • List the records required under GLP
  • List the data recording rules intended to demonstrate the integrity of nonclinical study data
  • Describe the retention period for GLP study data

Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.