This symposium reviews the different types of regulations and standards for the design of laboratory services for both research and health care delivery. These include GLP, GCLP, ISO 15189, ISO 17025 and others. The basics of each standard are highlighted showing key considerations for human and laboratory animal research. A scalable training program is described, that matches a series of one hour live and web-based tutorials with the regulations, standards, guidance, advisories, and compliance program guidance from a variety of regulatory agencies. The fulfillment of training requirements, leads to a well prepared organization that can withstand regulatory scrutiny. In this regard, the speakers will review GLP inspection readiness, including what documentation is expected to be readily available and how to avoid inspection findings.

Learning Objectives:
Identify a basic understanding of GLP regulations, guidance such as GCLP, and standards such as ISO 15189 and 17025
Discuss a scalable live and web-based training program that can be developed and implemented to assure compliance with the regulations, guidance, and standards
Interpert for an FDA GLP regulatory inspection - learn about the types of documentation that the Agency will audit and how to avoid significant GLP findings.