A Kaplan EduNeering course

Non-clinical laboratory studies are one of the first steps taken in bringing a new drug, device, or biologic to the marketplace so it is important that practices are in place to ensure the reliability of the study and the safety and efficacy of the product.  This lesson is intended to give the learner an introduction to Good Laboratory Practice Regulations (GLPs) and their application to non-clinical laboratory studies.

This lesson provides the learner with an understanding of terminology and acceptable practices for non-clinical laboratory studies and the role that Good Laboratory Practices play in assuring the validity of these studies.

Topics include:
      ·          What are GLPs
      ·          GLP Guidance
      ·          How do GLPs regulate personnel?
      ·          How do GLPs regulate a protocol?
      ·          Documentation required by GLPs
      ·          Why are GLP inspections conducted