Good Laboratory Practices
BIOL-40085
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 Information
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This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
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Instructor: Linda Manza, Ph.D.
Consultant
Linda Manza, Ph.D., is a consultant who has worked on all aspects of GLP including developing protocol and procedural training for GLP Tox studies. Previously she was the Associate Director of Quality Assurance at Arena Pharmaceutical where she served as Lead during FDA GLP Inspection and compiled, reviewed, and submitted responses to FDA 483 observations. Additionally, she was in the Army reserve and was in charge of a 440 member hospital unit during peace time and was the Company Commander of a 40 person Medical Support unit deployed in support of Operation Iraqi Freedom.
She received a Ph.D. in Pharmacology and Toxicology from the University of Arizona, Tucson, a M.S. in Toxicology from San Diego State University, Graduate School of Public Health, and a B.A. in Biological Sciences and Chemistry from the University of California Santa Barbara, College of Creative Studies.
Linda has been an active member of ASIW- SD since 2007.
