Workshop on Good Laboratory Practices and Quality Assurance

Program overview:
Good Laboratory Practice is defined as a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. The importance of implementing Good Laboratory Practices is to ensure quality in test data, good management of quality, reliability, the integrity of studies and traceability of data. This can be applied to non-clinical testing in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals.

For whom:
Laboratory Managers, Supervisors, Technicians, Analysts, Quality Control/Assurance staff etc.

Learning Objectives:
At the end of this program, participants will be able to:
• explain the principles of good laboratory practice;
• develop an understanding of quality management system;
• practice safety in laboratory operations;
• ensure the quality and integrity of test data; and
• obtain results that are:
o reliable
o repeatable
o auditable
Course outline:
Day 1: Module 1 Good laboratory practice: Overview
• What is GLP
• The principles of GLP
• Definitions of GCLP and GMP
• The history of GLP
• Documentation
• Standard operating procedures
• Results and reports
• Document control

Module 2: Requirements for facilities
• Size
• Construction
• Requirements for equipment
• Purchasing
• Calibration
• Maintenance
Module 3: Test and reference items
• Handling
• Records
• Storage
• Transport
Day 2 Module 1: Occupational health and safety
• Safety in the laboratory
• The correct use of chemicals and reagents
• Safety and storage
• Waste disposal
• Types of waste
• Correct handling and disposal
Module 2: Quality Assurance
• What is Quality System?
• Basic Consideration for Quality System
• Protocol (Or Study Plan) Review
• Sop Review
• Planning (Master Schedule, Inspection Plan)
Module 3: Quality Assurance Statement
• Elements of Quality System
o Audits and Inspections
• Quality Assurance vs. Quality Control
o QA Inspections of Suppliers and Contractors
• Elements of Quality Improvement
o Issuing and Archiving of QA Files and Reports

Training Methodology
• Lectures, discussions, exercises, case studies, audio-visual aids will be used to reinforce these teachings/learning methods.