This lecture-based, 2.5-hour live webinar covers the FDA's current Good Laboratory Practice (cGLPs) regulations and how they affect the conduct of nonclinical laboratory safety studies. This course introduces the various elements of cGLPs 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. This course fulfills the FDA’s cGLP annual training requirement for personnel involved in nonclinical laboratory studies.
Attendees will be able to:
· recognize when GLP protocols apply, explain their purpose and impact on laboratory work
· recall the history of GLP and the role of the FDA
· recognize legislation and definitions in the Drug Discovery Approval process
· understand the FDA GLP Regulations as defined in 21 CFR 58
New offering coming soon!