Reading Between the Lines: Dealing with Gaps in GLP Regulations (700945LIVE)
|Event Date/Time: Sep 30, 2008|
This webinar is targeted to scientists and management new to GLPs.
The Good Laboratory Practice regulations instituted by the FDA in the 1970s were developed to ensure the accuracy and integrity of preclinical drug and device studies. These GLPs consist of certain simple but defined methods for assuring that test articles are safe and effective before being tested in clinical studies. This presentation reviews the major areas described in FDA 21 CFR Part 58, particularly emphasizing the five key elements of preclinical studies: written procedures, personnel, equipment, data collection, and reporting. The key roles of the QAU, study director and management are reviewed.