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Highlights of FDA GLP
Abstract:

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.



Course Outline:

  • Introduction: FDA’s Recent Directives
  • The GLP Organization: Management, Sponsors, Study Directors and Other Roles
  • Facilities
  • Equipment: Instruments, Gadgets
  • Reagents & Solutions
  • Test Articles
  • Test System
  • Protocols: Development/Execution
  • SOPs and Documentation
  • GLP Study Conduct
  • GLP Final Report
  • Archiving
  • Quality Assurance Unit
  • Subcontracting CROs
  • Regulatory Aspects/Disqualifications
  • Validation & Qualification Issues
  • CFR 21 Part 11
  • Methods Validation
  • Equipment Qualification - IQ/OQ/PQ
  • References & Acknowledgements
  • Conclusion