Quality control within laboratories, especially those running clinical trials, is vital to ensure precision and accuracy of the results. Quality control also enables any issues within the processes to be more easily identified and corrected, ensuring reliable and robust data.

This workshop provides an introduction to the different aspects of laboratory quality control, including GCP/GCLP, documentation, laboratory infrastructure, the readiness checklist, auditing and the road to accreditation. This workshop is aimed at laboratory management staff in low and middle income countries. 

The workshop will be broken down into these topics in two 4-hour sessions over the two days. Teaching will be a combination of presentations and discussions, with breakout sessions, case studies and example documentation.

Join the discussion group to share your reflections on the programme. 

Certificates of Attendance will automatically be issued to eligible participants once we have confimed you meet the criteria. Please refer to The Global Health Network's certificates policy for more information.

Thank you to those who attended this workshop and the presenters and organisers. The workshop materials and recordings will be made available very soon on this page.  

Workshop Sessions 

DAY 1 - Wednesday 21 October - Outline 

Time

Introduction

 

09:00-09:15

Introduction to quality control and GCP/GCLP

  • Identifying what you want from your laboratory
  • GCLP/GCP
  • Discussion session

09:15-10:00

 

Coffee Break 

10:00-10:15

Documentation

  • Importance of documentation - Basis of Quality Management System (QMS) 
  • Essential documents required for QMS
  • Document control process 
  • Document requirements             
  • Master list index
  • Compliance with documentation must be assessed and reviewed (internal/external audits)
  • Example of SOP template and Master list Index

10:15-11:30

 

Coffee Break

11:30-11:45

Quality management - readiness checklist

  • Equipment Service schedule or service contract in place; all servicing & calibration up to date and reports available
  • Staff training (assays, safety, competency assessment) and CVs  up to date and documented
  • Appropriate health and safety measures in place and documented
  • Quality Management Plan/SOP in place and up to date

11:45-12:30

Wrap up session

  12:30-13:00

Workshop Sessions 

DAY 2 - Thursday 22 October - Outline

Time

Infrastructure and utilities 

  • BSL levels
  • Utilities
  • Waste disposal pathways
  • Computerised laboratory management systems
  • Calibrating equipment yourself – guidelines
  • Contingency plans

09:00-09:45

 

Coffee break

09:45-10:00

Quality management - auditing 

Areas to be audited:

-        Facilities
-        Systems
-        Equipment
-        Methods
-        Quality control procedures
-        Personnel
-        Reports
-        documentation

  • Laboratory readiness checklist
  • Recording and processing samples
  • Applicable training on quality system requirements
  • Recording of data
  • Internal and external audit
  • Reagent and sample batch tracing 
  • Continuous QC improvement form, contamination rates, reagent QC forms

10:00-11:15

 

Coffee Break

11:15-11:30

Working towards accreditation 

  • SLMTA (Strengthening Laboratory Management Toward Accreditation) 
  • WHO - SLIPTA (Stepwise Laboratory Improvement Process Towards Accreditation) 
  • African society for laboratory medicine (ASLM) 
  • ISOs

11:30-12:30

Wrap up session

  12:30-13:00