Introduction to Good Laboratory Practice (GLP)

Good Laboratory Practice (GLP) is a globally recognized quality system that ensures the reliability, integrity, and traceability of non-clinical laboratory studies. Regulatory authorities rely on GLP-compliant data to evaluate product safety and ensure compliance before clinical trials.

Developed by Regulatory Affairs experts with qualifications from Northeastern University, Boston, this interactive online course combines theory with real-world application. By completing this course, you will gain the knowledge to apply GLP principles and support compliant, high-quality laboratory operations.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Laboratory personnel involved in non-clinical studies
• Quality assurance and quality control professionals
• Regulatory affairs specialists
• Professionals working in pharmaceutical, biotech, or CRO laboratories

 
🎯 What you’ll learn?

• Principles and purpose of Good Laboratory Practice (GLP)
• Role of GLP in non-clinical studies and drug development
• Responsibilities of laboratory personnel and Quality Assurance Units
• How to ensure reliable, compliant, and audit-ready laboratory data

Curriculum

Introduction
Lesson 1: The History of GLP

• GLP Regulations in 1979 and 1980
• First OECD Principles of GLP
• Globalization of GLP

Lesson 2: The Drug Development Process and The Role of GLP

• Phase 1
• Phase 2
• Phase 3
• Phase 4

Lesson 3: “Resources” as a Fundamental Point of GLP

• Organization and Personnel
• Facilities and Equipment

Lesson 4: “Rules” as a Fundamental Point of GLP

• Protocols
• Written Procedures
• The Study Director

Lesson 5: “Characterization” as a Fundamental Point of GLP

• The Test Item
• Test System

Lesson 6: “Quality Assurance” as a Fundamental Point of GLP

• Protocol (or Study Plan) Review
• SOP Review
• Planning
• Adults and Inspections

Glossary
Conclusion
Quiz