Introduction to Good Laboratory Practice (GLP)
This course covers the fundamentals of laboratory equipment and facilities, including equipment setup, calibration, verification, validation, qualification, maintenance, and inventory management for reagents and supplies.
Duration : 2 hour(s)
Skill level: Regulatory
Final exam: Yes
Certificate of Completion: Yes
CEU / CPD Accreditation: Yes
Certification:
Successful completion provides learners with a dated, traceable and downloadable certificate for the course : Introduction to Good Laboratory Practice (GLP)
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through GXP's certificate online checker. They can also be shared on Linkedin.
Description:
Good Laboratory Practice (GLP) is a globally recognized quality system that ensures the reliability, integrity, and traceability of non-clinical laboratory studies. Regulatory authorities depend on GLP-compliant data to assess product safety before clinical trials can begin.
This course provides a practical introduction to GLP principles and their application in regulated laboratory environments.
What you’ll learn?
- Principles and purpose of 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
Who should enroll?
- Laboratory personnel involved in non-clinical studies
- Quality assurance and quality control professionals
- Regulatory affairs specialists
- Study director
- Facility management
- Archivists
- Professionals working in pharmaceutical, biotech, or CRO laboratories
Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.
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
Lesson 6: “Quality Assurance” as a Fundamental- Point of GLP
- Protocol (or Study Plan) Review
- SOP Review
- Planning
- Adults and Inspections
Conclusion
Assessment
