By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical laboratory research, QA audit programs and FDA inspections. You will gain an in-depth understanding of specific critical GLP requirements such as the role of the QAU, study director, test and control articles. Preparation for FDA GLP inspections and current inspection trends, basic elements of GLP documentation, and considerations for lab facilities, equipment, and animals are covered.
Course Number: BIOL-40085
Credit: 2.00 unit(s)
Related Certificate Programs: Clinical Trials Design and Management, Regulatory Affairs Essentials
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6/22/2020 - 8/24/2020