Course Title:

Good Laboratory Practices ( GLP & GCLP )


Colorado State University OnlinePlus

Fort Collins, Colorado, United States

Course format: Online

Learn about the FDA and the Organization for Economic Cooperation and Development (OECD) principles of Good Laboratory Practices (GLP) as they apply to the regulation and quality of non-clinical studies utilized to support regulatory submissions. Topics to include personnel, animal facilities, equipment, organization, 21 CFT part 11 applicability, product and process controls as well as documentation and how these affect data integrity and regulatory submissions. Discussions to include an overview of the Good Clinical Laboratory practices (GCLP) as they pertain to reliability and integrity of data generated by analytical laboratories. ...

Elements of this syllabus are subject to change.

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Phone No.: (877) 491-4336

School Address/Venue(s):

2545 Research Blvd.
Fort Collins, CO 80526

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