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This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

www.GlobalHealthLaboratories.org. This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

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This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

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  1. www.GlobalHealthLaboratories.org This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions.

  2. GCLP GOALS & OBJECTIVES INTRODUCTION & BACKGROUND KEMRI-Wellcome Trust Research Programme

  3. Course Purpose • The Good Clinical Laboratory Practices (GCLP) is a course that is designed for every one with a responsibility in a Clinical Laboratory

  4. Course Goals & Objectives • To internalize the GCLP principles, concept and practices. • To empower Laboratory staff (knowledge and skills) which will enable staff to: • Manage the Laboratory resources and facilities. • Run the Laboratory in more professional manner. • Build an effective and efficient compliant laboratory facility to: • Provide confidence with Laboratory results • Control the Lab processes.

  5. BENEFITS OF GCLP COMPLIANCE • Lab results (research or diagnostic) Reliable, Reproducible & Auditable. • The incidences of false negative and false positives is reduces • Results are assured to be of highest quality • Results are comparable to those in USA, Europe, Australia etc • Build Confidence to staff, sponsors and clients • Resources are efficiently managed • Uniformity and standardization of systems.

  6. What is GCLP? • Set of guidelines that promotes the Quality and Validity of test data

  7. GCLP OBJECTIVES • Ensure Consistent, reproducible, auditable and reliable Laboratory results. • Ensure the quality and integrity of data. • Allows for accurate reconstruction of experiments performed in the Laboratory. • Monitor data quality and allows comparison of test results regardless of performance location.

  8. Benefits of GCLP Compliant • Results are assured to be of the highest quality. • Wasting of resources is minimized. • The incidences of false positive and false negative is reduced. • Results can be compared to other results. • The results are assured of Reliability, Reproducibility, Repeatable & Auditable.

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