Good Clinical Laboratory Practice (GCLP)
he 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.
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
A group of experts will facilitate the workshop
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
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