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Good Laboratory Practice (GLP) regulations are codified in 21 CFR Part 58 and are applicable to all non-clinical studies that support applications on research or marketing permits for products regulated by the FDA, other national agencies and the EPA. A GLP complaint laboratory not only satisfies the applicable regulations, but also supports the organization’s business needs by being efficient and generating quality data which in turn supports quality project decisions.
The GLP regulations require that each individual engaged in the conduct of or responsible for the supervision of a non-clinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. One of the required training components is on the GLP regulation, which will be provided by this seminar. This full day live and interactive web training curriculum begins with an overview of CFR 21 Part 58, including discussion on the requirements for the equipment, facility, organization, study protocols and reports, as well as archives. The SOPs required to conduct a GLP study in each of the key GLP areas will be addressed in detail. The emphasis of the course will be on the set up and operation of a GLP compliant Laboratory, as well as the ways in which laboratory systems can be designed to improve efficiency. The course will also cover specific issues faced by attendees in their laboratories, including examples of warning letters from the FDA website, to understand do’s and don’ts. Training Agenda: AM 10:00 – 10:30 Login & Setup
10:30 – 11:15 GLP regulations overview
11:15 – 11:45 GLP requirements for facility, personnel and study protocols
11:45 – 12:00 Live Q&A Break 12:00 – 1:00 Lunch Break PM 1:00 – 2:00 GLP requirements for Test articles, Lab operations and Equipment
2:00 – 2:15 Live Q&A
2:15 – 2:30 Short Break
2:30 – 3:15 Specific areas of lab operations as requested by attendees
3:15 – 3:45 GLP requirements for Records and Archives
3:45 – 4:15 Extended Q&A and Group Discussion
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