Do You Need GLP Training? The FDA promulgates the GLPs for conducting nonclinical
laboratory studies that support or are intended to support applications for research or marketing permits
for regulated products. Products affected include food and color additives, animal food additives, human
and animal
pharmaceuticals, medical devices for human use, biologic products, and electronic products.
In order to ensure quality control and to provide consumer protection, the agency issued the GLP regulations. The regulations specify minimum standards for the proper conduct of safety testing and contain sections on facilities, personnel, equipment, standard operating procedures (SOPs), test and control articles, quality assurance, protocol and conduct of a safety study, records and reports, and laboratory disqualification.
As appropriate, EPA and OECD information are also included, especially guidelines for Multisite Studies.
The Agency expects that Sponsors and Management be trained in GLPs to ensure that they are aware of their GLP responsibilities. |
All courses are intended to be interactive, as attendees are encouraged to participate in discussions and workshops. Courses will also portray realistic approaches to applying the GLPs in the laboratory.
Training courses have been planned to take place throughout the US and Canada to facilitate easy access. To locate a course near you, click on the session links above. Additional training course locations will be scheduled; contact our Training Division for more details. |