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Laboratory Management Systems ISO/IEC 17025:2017 Course & Certification
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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
- What is ISO/IEC 17025:2017?
- History & Evolution of the Standard
- Key Changes: 2005 → 2017
- Clause Structure at a Glance
- ISO/IEC 17025:2017 vs ISO 9001:2015 – Understanding the Difference
- Key Terminology Defined (Clause 3)
- Which Laboratories Need ISO/IEC 17025?
- Impartiality (Clause 4.1)
- Impartiality in Practice: Worked Scenario
- Confidentiality (Clause 4.2)
- Confidentiality: How to Handle Real-World Situations
- Legal Entity & Organisational Structure (Clause 5)
- Sample Laboratory Organisational Structure
- Key Roles & Responsibilities
- Defining Laboratory Scope – What to Include
- Personnel Competence (Clause 6.2)
- Competency Training Matrix – Worked Example
- Facilities, Environment & Equipment (Clauses 6.3 & 6.4)
- Equipment Calibration Record – Example Template
- Metrological Traceability (Clause 6.5)
- Setting Calibration Intervals – Decision Framework
- Externally Provided Products & Services (Clause 6.6)
- Review of Requests, Tenders & Contracts (Clause 7.1)
- Contract Review in Practice: Worked Scenario
- Method Selection, Verification & Validation (Clause 7.2)
- Method Validation Parameters – Complete Reference
- Sampling & Handling of Test Items (Clauses 7.3 & 7.4)
- Handling a Non-Conforming Sample on Receipt – Scenario
- Technical Records & Measurement Uncertainty (Clauses 7.5 & 7.6)
- Measurement Uncertainty Budget – Step-by-Step Example
- Reporting Results & Non-Conforming Work (Clauses 7.8 & 7.10)
- Statement of Conformity & Decision Rules (Clause 7.8.6)
- Management System Options: A and B (Clause 8.1)
- Document Hierarchy in a Laboratory Quality Management System
- Documentation & Records Control (Clauses 8.2–8.4)
- Document Version Control – Worked Example
- Risks, Improvement & Corrective Actions (Clauses 8.5–8.7)
- Risk Register – Practical Template & Example
- Internal Audits & Management Reviews (Clauses 8.8 & 8.9)
- Internal Audit Programme – Annual Schedule Example
- International Accreditation Landscape
- Steps to Achieve Accreditation
- Pre-Assessment Gap Analysis Checklist
- Maintaining Accreditation
- Common Non-Conformities at Assessment
- Root Cause Analysis: 5-Why Example
- Key Terms & Glossary (Part 1)
- Key Terms & Glossary (Part 2)
- Course Conclusion – Key Takeaways
Course Benefits
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 GCLP 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 GCLP legislation through the application of learning outcomes. The course is written by Louise Handy, who is a past chairperson for the Research Quality Assurance (RQA)
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