This lecture-based, 3-hour live webinar covers FDA’s current Good Laboratory Practice (CGLP) regulations and how they affect the conduct of nonclinical laboratory safety studies. This course introduces the various elements of CGLP as described in 21 CFR 58 and topics include a discussion of the requirements for the study director, quality assurance unit, personnel and testing facility management and operations, test and control articles, equipment, study protocol and implementation, documentation and archival of records and materials.
This course fulfills FDA’s CGLP annual training requirement for personnel involved in nonclinical laboratory studies.
