Good Clinical Laboratory Practice

Introduction

Good Clinical Laboratory Practice (GCLP) is a set of guidelines for laboratory samples from clinical studies which ensures the reliability, quality, consistency and integrity of data generated by clinical trial laboratories.

There is need for iterative patient safety and reliability of data generated by laboratories; therefore the environment under which the studies are conducted should be thoroughly scrutinized against set guidelines and maintained if this is to be achieved.

Target group

The course is designed for professionals managing or working in Laboratories for various fields, including research, clinical, pharmaceutical, food industries and hospitals.

Objectives: 
Upon successful completion of the course, the participants will be able to

• Describe Good Clinical Practice and Good Laboratory Practice as used in the context of Good Clinical Laboratory Practice guidelines
• Understand the principles of GCLP and the requirements of each principle.
• Identify how GCLP is implemented across the whole clinical trial process 
• Understand the benefits of GCLP compliance to laboratories
• Apply and implement the GCLP guidelines in a laboratory

Course content

Introduction to the concept GCP, GLP and GCLP

• History
• The scope of application
• Benefits

Guidelines for Organizations Personnel

• Trial Facility Management Responsibilities
• Analytical Project Manager Responsibilities
• Trial Staff Responsibilities

Guidelines on Lab Facilities

• Trial Facilities
• Archive Facilities
• Waste Disposal

Equipment, Materials and Reagents

• Equipment
• Material
• Reagents
• Receipt
• Chain of Custody
• Logistics

Standard Operating Procedures (SOPs)

• Development and review of standard operating procedures
• Application of Standard Operating Procedures

Planning and conduct of the work

• Analytical Plan
• Content of the Analytical Plan
• General
• Computer Systems
• Method Validation
• Processing trial materials

Guidelines for Reporting and documenting results

• General
• Analytical Report
• Content of the Analytical Report
• Analytical results
• Quality Control
• Quality Audit
• Storage and Retention of Records
• Confidentiality

Course prerequisites

• Participants should be proficient in English

For comment or clarification contacts us on

Tel: +254204400942 or +254706582430
Email: [email protected]