The Mycetoma Research Centre

University of Khartoum

WHO Collaborating Centre on Mycetoma

 The Mycetoma Research and Development Arcade

 

Workshop Overview

Good clinical laboratory practice (GCLP) workshop provides and discusses the quality system principles and procedures that the clinical laboratories should carry out to provide consistent, reproducible, reliable laboratory results. This workshop will offer unique, comprehensive guidance on implementing GCLP in the laboratories.

 

Workshop Facilitators

A group of experts will facilitate the workshop, and among them:

  • Dr Sahar Mubarak Bakhiet, Sudan
  • Dr Najwa Adam Mhmoud, Sudan
  • Mr Emmanuel Edwar Siddig

 

Learning Objectives

By the end of the course, participants will have a good understanding of:

  • What is a GCLP
  • What are the GCLP principles and the requirements of each one
  • Identify how GCLP compliance benefits laboratories
  • Identify how GCLP is implemented across the whole clinical trial process
  • Laboratory management; facilities, organization and personnel
  • Scientific analysis, reporting and archiving
  • What are the Standard Operation procedures and their importance
  • Laboratory quality assurance
  • Equipment maintenance
  • Data archiving and retention

 

Workshop Programme

 

Time

Topic

Saturday

09:00 – 11:00

Welcome address

Training objectives and orientation

Ground Rules

11:00 – 11:30

Tea and coffee

11:30 – 12:00

GCLP implementation successes and challenges

12:00 – 13:00

Discussions

13:00 – 13:30

Lunch

13:30 – 14:30

Questions & Answers

Sunday

09:00 – 11:00

Process Control:

Samples management

Case studies and discussion

11:00 – 11:30

Tea break

11:30 – 13:00

Process Control:

Quality control

Method validation

Case studies and discussions

13:00 – 13:30

Lunch

13:30 – 15:00

EQAS & audits case studies

Internal and external quality control

Discussion - group activity

15:30  - 16:30

Demonstration of the use of temperature monitor

Monday

9:00 – 9:30

Recapitulation of previous days

9:30 – 10:30

Data and information management

Case studies

10:30 – 11:00

Group activity and discussion

11:00 – 11:30

Tea break

11:30 – 13:00

Facilities, safety and security

Equipment and inventory

Group activity & presentations

13:00 – 13:30

Lunch

13:30 – 15:00

Personnel, Documentation

Free discussion

15:00 – 15:30

Coffee break

15:30 – 17:30

Course Evaluation

Closing ceremony

 

 

Instruction Methods

This workshop is a hands-on training activity with various interactive instructional techniques. There will be brief presentations, with many small group teaching, discussions and presentations. There will be many homework assignments and groups presentations. Case studies and Sharing experience session will be included in the workshop.

 

Who Should Attend

The target attendees are medical and health professionals, microbiologists, pathologists, laboratory directors, managers, and technologists. QA/QC officers and Quality officers, and managers, as well as other scientists who share an interest in the field of clinical trials and experimental research.

 

Workshop Duration

It is a three-day intensive workshop.

 

Workshop Coordinator

Mr Emmanuel Edwar Siddig

 

How will the assessment be done?

  • Pre-workshop MCQs to assess the prior participants' basic knowledge
  • Interactive sessions
  • Post-workshop MCQs to assess the acquired knowledge and certificate will be awarded after achieving the minimum pass score.
  • Those who fail to achieve this score will be offered a second attempt to take the following workshop's post-workshop assessment.

 

Workshop Evaluation

  • Oral and written participants and workshop facilitators feedback will be obtained

 

How to Apply

To apply for the course, please complete the Online Application Form

 

CPD Credits

5 CPD credits

 

Instruction Language

English

 

Contact Us

Mr Emmanuel Edwar Siddig

Workshop coordinator

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Tele: 00249991398388

         00249911300998

 

Workshop Dates

Three times per year

 

Teaching Materials

  • British Association of Research Quality Assurance (BARQA) (2003) Good Clinical Laboratory Practice Version 1 (available as World Health Organization (2009) Good Clinical Laboratory Practice) 19 March 2015.
  • European Medicines Agency (EMA) Good Laboratory Practice Compliance: 19 March 2015
  • Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. (2009) Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I–III Clinical Trials. PLoS Med 6(5): e1000067.
  • World Health Organization (2009) https://www.who.int/tdr/publications/documents/gclp-web.pdf