Resources: Reference library, Glossary

Module Overview

Duration:
This module should take 60-120 minutes to complete

Certification:
A certificate is issued once a minimum of 80% is achieved in the final quiz section

Prerequisites:

  1. ICH Good Clinical Practice

  2. Introduction to Good Clinical Laboratory Practice

  3. GCLP: Organisation & Personnel

Summary:
'Facilities, Equipment, Materials & Reagents' is the third module of the seven module course 'Good Clinical Laboratory Practice'. This module provides a detailed analysis of GCLP guidance for laboratory facilities including biosafety, design, workflow, security, archiving and waste disposal. It also analyses GCLP guidance for equipment, materials and reagents utilised in the laboratory and how they are implemented and managed.

Objectives:
Upon successful completion of this course, you should be able to:

  • Recognise the requirements of laboratory facilities with regards to work space and flow of work through the laboratory
  • Describe the different areas of the laboratory and how they should be arranged
  • Understand the factors involved in instrument selection, installation, training, evaluation and documentation
  • Implement methods to verify performance  of laboratory equipment
  • Use and/or develop logs to adequately document maintenance, repair, calibration and corrective action
  • Develop and implement an equipment, material and reagent management program and good inventory control

Acknowledgements

The Global Health Training Centre is built through the support and partnership of the Bill and Melinda Gates Foundation, the World-Wide Antimalarial Resistance Network and The East African Consortium for Clinical Research.

Authors:

Carmelita Africa - Clinical Project Associate, International Partnership for Microbicides. Web

Liam Boggs - Training Manager, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford. Web

Paramesh Chetty - Senior Manager,Clinical Laboratory Programme - Africa, International AIDS Vaccine Initiative (IAVI). Web

Rhea Coler - MSc, PhD, VP, Preclinical Biology, Infectious Disease Research Institute (IDRI). Web

Tracey Day - Ph.D. Scientist, Infectious Disease Research Institute (IDRI). Web

Helen Demarest - Associate Director, Clinical Operations, Medicines for Malaria Venture (MMV). Web

Sabine Dittrich - Senior Scientific Officer, Foundation for Innovative New Diagnostics (FIND). Web

Sebastian Gelderbloem - Managing Director, Aeras Africa. Web

Lakshmi Jayashankar - PhD, Senior Scientific Officer, Columbus Technologies and Services, Contractor to National Institutes of Health, USA.

Wendy Keller - Quality Assurance Manager, DNDi - Drugs for Neglected Diseases initiative. Web

Troy Leader - PhD, Scientific Program Officer, Diagnostics Global Program, PATH. Web

Mahnaz Vahedi - Special Programme for Research and Training in Tropical Diseases. Web

Reviewers:

Maureen Lambrick - Sr. Manager Lab Development Services, Tuberculosis, Aeras Africa

Motiur Rahman, MBBS, PhD - Head of Laboratories, Centre for Tropical Medicine, Oxford University Clinical Research Unit, HO CHi Minh City, Vietnam

Use and reproduction of these e-learning materials:
These e-learning materials are owned by the Global Health Network. You are free to share or adapt this material but you must attribute it to the Global Health Network using the link www.theglobalhealthnetwork.org

 

Resources: Reference library, Glossary

Your feedback is greatly appreciated; please take a couple of minutes to tell us your thoughts on this course:

Click here to take survey