Good Clinical Laboratory Practice (‎GCLP)‎

GCLP is a set of guidelines essential for any organization involved in the analysis of samples from Clinical Trials, ensuring compliance with Good Clinical Practice (GCP) requirements. Established in 2003 and endorsed by the World Health Organisation (WHO) in 2006, GCLP provides a standard for laboratories handling clinical trial samples.

Who should enroll ? Our certified and engaging GCLP training is designed for sponsors, laboratory managers, project managers, Clinical Research Associates (CRAs), and quality assurance personnel. This training offers a comprehensive understanding of the quality system framework necessary for the analysis of clinical trial samples, ensuring all laboratory processes and results meet GCLP standards.

Topics outlined in the course :

• Understand GCP, GLP, and GCLP Differences
• Learn why GCLP is essential and understand its development process.
• Principles of GCLP:
  • Organisation and Personnel
  • Facilities
  • Equipment, Materials, and Reagents
  • Trial Materials
  • Conduct of Work
  • Quality Control (QC) and Quality Audit (QA)
  • Storage and Retention of Records
• Practical steps to ensure workplace compliance with GCLP standards.
• Clinical Trial Protocol and Analytical Plan: : How to develop and utilize these documents to support GCLP compliance.
• Sample Management: Effective methods for collecting and analyzing samples.

This is a comprehensive certified course covering all required elements of GCLP through an interactive online experience. Case studies and quizzes follow each lesson to reinforce learning. Upon completion, participants will receive an internationally recognized GxP Training certificate, accredited with CPD/CEU credits.

Curriculum:

Introduction

Lesson 1: Good Clinical Practice

Lesson 2: More Than GCP

Lesson 3: Good Laboratory Practice

Lesson 4: GCP vs GLP

Lesson 5: Good Clinical Laboratory Practice

Lesson 6: Principles of GCLP

Lesson 7: Implementation of GCLP

Conclusion

Glossary

Evaluation