Methodology for verification of GLP studies

A few hours
Beginner

Course details

The course elaborates on the criteria and methodology for verifying GLP studies submitted within an application for regulated products. 

This course consists of three modules delivered by the Austrian Agency for Health and Food Safety (AGES) and the Greek Benaki Phytopathological Institute (BPI). The first two modules provide an overview of the OECD GLP Principles and relevant guidance documents, and explain the criteria for using the GLP verification checklist, while the third module provides a practical demonstration of the checklist using case studies.

Target audience

The course is aimed at GLP assessors and risk assessors in Receiving Authorities (EFSA and Member States competent authorities) involved in the evaluation of dossiers for regulated products under EFSA’s remit. The course is also of interest for applicants (study sponsors) and test facilities (study directors) for reporting data in study reports in accordance with GLP criteria.

Learning objectives

On successful completion of this course you will be able to:

  • Understand the OECD GLP Principles
  • Use the GLP verification checklist for verifying GLP studies submitted within an application for regulated products
  • Identify potential GLP observations and possible needs for clarifications in GLP studies

Offered by

EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.

Enrol
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Schedule

  1. Welcome
  2. Module 1 - Theory & background
  3. Module 2 - Practical demonstration on GLP verification checklist
  4. Module 3 - Practical demonstrations on specific studies

Tags

food safety and quality

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