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Good Laboratory Practice (English) Course & Certification
Intermediate
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6 hours
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Good Laboratory Practice (English)
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About
Good Laboratory Practice (GLP) is a quality system that ensures the consistency, reliability, integrity, and traceability of non-clinical laboratory studies. Widely adopted by regulatory authorities worldwide, GLP helps laboratories generate high-quality data that supports research, product development, and regulatory submissions.
This Good Laboratory Practice (English) Course & Certification provides a practical introduction to GLP principles, laboratory responsibilities, documentation requirements, quality assurance, data integrity, and regulatory compliance. Upon successful completion, learners receive a certificate demonstrating their understanding of internationally recognized GLP standards.
Who Should Enrol?
- Laboratory Analysts and Technicians
- Quality Assurance and Quality Control Professionals
- Research Scientists and Laboratory Managers
- Pharmaceutical, Biotechnology, and Healthcare Professionals
- Regulatory Affairs Personnel
- Academic and Research Staff
- Life Science, Pharmacy, and Biotechnology Graduates
- Anyone seeking GLP certification or refresher training
What you will learn
Understand Good Laboratory Practice (GLP) principles, regulatory guidelines, and test facility organisation in non-clinical laboratory studies.
Learn quality assurance processes, SOPs, study performance procedures, and laboratory compliance requirements.
Develop knowledge of laboratory systems, computerized system validation, data management, and reporting procedures.
Gain understanding of record retention, archiving practices, and quality standards followed in non-clinical research environments.
Course Syllabus
- Background
- The FDA Investigation into IBT
- GLP Is Born
- What Is GLP?
- Why Do We Need GLP?
- The Evolution of GLP
- The Role of the OECD
- Overview
- Management Responsibilities I
- Management Responsibilities II: Test Facility Management
- Management Responsibilities III: Test Site Management
- Study Director Responsibilities
- Principal Investigator Responsibilities
- Study Personnel Responsibilities
- Overview
- Study Plans, SOPs, and the Master Schedule
- Inspections
- Final Reports
- Reporting QA Findings
- The QA Statement
- Test Facility and Test Site QA Differences
- Overview
- Test System Facilities
- Facilities for Handling Test and Reference Items
- Archive Facilities
- Waste Disposal
- General Requirements I: Apparatus
- General Requirements II: Materials
- General Requirements III: Reagents
- Fitness for Purpose
- Computerized System Validation
- Overview
- Physical/Chemical Test Systems
- Biological Test Systems I: Health Status
- Biological Test Systems II: Identification
- Biological Test Systems III: Sanitization
- Biological Test Systems IV: Separation
- Definitions
- Receipt, Handling, Sampling, and Storage
- Characterization
- Reserve Samples
- General Requirements
- Expected Coverage
- Deviations
- Overview
- Content of the Study Plan
- Amendments
- Deviations
- Raw Data I: Overview
- Raw Data II: Requirements
- Overview
- Content of the Final Report
- Amendments I: Overview
- Amendments II: Additional Work
- Amendments III: Reformatting
- Overview
- Retention Periods
- Submission to the Archive
- Retention
- Disposal and Transfer
- Electronic Data
- Overview
- Suppliers
- Field Studies
- Short-Term Studies
- Computer Systems
- Sponsors
- Multi-Site Studies
- In Vitro Studies
- Overview
- Inspection Types I: Prospective Membership
- Inspection Types II: Full Membership
- Inspection Types III: Study Audits
- Overview
- MAD and GLP
- Glossary
- Bibliography
- 📘 Bonus: Good Laboratory Practice (GLP) eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any legislative changes in GLP as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed to ensure that you comply with GLP legislation through the application of learning outcomes. The course is written by Roger Chapman, internationally recognised expert in the application of OECD GLP principles and Quality Assurance systems.
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