This Training is designed to provide a comprehensive guidance and practical help for laboratories to improve their quality and offer excellent services to research participants and patients. The training addresses current regulatory framework for laboratory work in support of clinical trials as well public health laboratories with reference to the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. It also borrows from the BARQA guidance document on Good Clinical Laboratory Practice (GCLP) and WHO document on strengthening laboratory management to wards accreditation (SLMTA). The course is structured to encourage participants fulfill the following: discuss and develop ideas, solve specific problems related to their areas of laboratory work and examine particular aspects of GCP, GCLP and SLMTA.
The scope of training covers the following areas of laboratory practice: Introduction to GCLP, Organization and Personnel, Facilities, Equipment and Materials, Computer Validation, Document Control, Writing of a Standard SOP, Internal and External Quality Control, Assessment of Laboratory Supplies and Research Ethics.