This training course will cover some of the major requirements, definitions and elements of various GLP regulations, and the FDA/OECD GLP’s. It scopes out the roles and responsibilities of the Study Director, Management and QAU function in GLP testing facilities. Comparison and differences between the FDA and OECD GLP’s will be included. The course aims at bringing out basic tenets and elements of GLP’s from the directives and regulations. The basic process of conduct of GLP studies including the development of GLP study protocols, final reports, archiving requirements of In Phase Audits, & other details will be included. Case histories, real-life applications, and group exercises are an integral part of this intensive course.
Introduction: FDA’s Recent Directives
The GLP Organization: Management, Sponsors, Study Directors and Other Roles