Course Details

This course is appropriate for a wide range of professionals but not limited to:

• Laboratory Managers and Supervisors
• Quality Assurance and Quality Control Personnel
• Chemists, Biologists, and Laboratory Technicians
• R&D and Analytical Scientists
• Environmental, Pharmaceutical, and Industrial Laboratory Staff
• Anyone involved in laboratory testing, reporting, or regulatory compliance

• Expert-led sessions with dynamic visual aids
• Comprehensive course manual to support practical application and reinforcement
• Interactive discussions addressing participants’ real-world projects and challenges
• Insightful case studies and proven best practices to enhance learning

By the end of this course, participants should be able to:

• Understand and apply the core principles of Good Laboratory Practice
• Establish and maintain a GLP-compliant quality management system
• Ensure data integrity, traceability, and proper documentation practices
• Maintain equipment calibration, validation, and maintenance schedules
• Identify and control potential sources of laboratory errors
• Implement corrective and preventive actions for continuous improvement

DAY 1

Introduction to Good Laboratory Practice (GLP)

• Welcome and Introduction
• Pre-Test
• History and Evolution of GLP
• Objectives and Importance of GLP in Laboratory Operations
• Regulatory Frameworks: OECD, ISO 17025, FDA, and WHO Guidelines
• GLP Principles: Organization, Personnel, Facilities, and Equipment
• Roles and Responsibilities of Laboratory Personnel
• Overview of Laboratory Quality Assurance Systems

DAY 2

Laboratory Organization, Facilities, and Equipment

• Organizational Structure for GLP Implementation
• Laboratory Facility Design and Environmental Conditions
• Equipment Qualification, Calibration, and Maintenance
• Reference Standards, Reagents, and Sample Management
• Equipment Logbooks and Calibration Records
• Handling, Labeling, and Storage of Test Materials
• Practical Workshop: Setting Up a GLP-Compliant Laboratory

DAY 3

Documentation, Data Management, and Quality Control

• Principles of GLP Documentation
• Standard Operating Procedures (SOPs): Writing, Approval, and Control
• Data Recording, Verification, and Archiving
• Chain of Custody and Data Integrity (ALCOA+ Principles)
• Internal Quality Control (IQC) and Proficiency Testing
• Recordkeeping and Reporting of Test Results
• Case Studies: Documentation Errors and Their Impact

DAY 4

Validation, Auditing, and Safety in Laboratories

• Method Validation and Verification Requirements
• Analytical Method Transfer and Change Control
• Internal and External Laboratory Audits
• Corrective and Preventive Actions (CAPA)
• Laboratory Health, Safety, and Environmental Controls
• Waste Handling and Chemical Hygiene Programs
• Emergency Procedures and Risk Assessment in Laboratories

DAY 5

Compliance, Continuous Improvement and Course Wrap-up

• Ensuring Compliance with GLP and ISO 17025 Standards
• Common Non-Conformities and How to Avoid Them
• Training and Competency Development for Laboratory Staff
• Continuous Improvement in Laboratory Quality Systems
• Post-Test
• Certificate Ceremony