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About

Good Laboratory Practice (GLP) – PV Laboratory Management Systems training based on ISO/IEC 17025:2017 focuses on establishing robust quality systems in testing laboratories. The course covers key requirements such as document control, method validation, equipment calibration, and data integrity. It emphasizes compliance, accuracy, and reliability of laboratory results in pharmaceutical environments. Suitable for laboratory professionals seeking alignment with international standards and accreditation requirements.

GLP – PV Laboratory Management Systems based on ISO/IEC 17025:2017 ensures laboratories operate with quality, accuracy, and compliance in testing and calibration activities. This course is recommended for laboratory managers, QA personnel, analysts, and professionals working in pharmaceutical and testing laboratories seeking accreditation and regulatory alignment.

Course Syllabus

  1. What is ISO/IEC 17025:2017?
  2. History & Evolution of the Standard
  3. Key Changes: 2005 → 2017
  4. Clause Structure at a Glance
  5. ISO/IEC 17025:2017 vs ISO 9001:2015 – Understanding the Difference
  6. Key Terminology Defined (Clause 3)
  7. Which Laboratories Need ISO/IEC 17025?

  1. Impartiality (Clause 4.1)
  2. Impartiality in Practice: Worked Scenario
  3. Confidentiality (Clause 4.2)
  4. Confidentiality: How to Handle Real-World Situations

  1. Legal Entity & Organisational Structure (Clause 5)
  2. Sample Laboratory Organisational Structure
  3. Key Roles & Responsibilities
  4. Defining Laboratory Scope – What to Include

  1. Personnel Competence (Clause 6.2)
  2. Competency Training Matrix – Worked Example
  3. Facilities, Environment & Equipment (Clauses 6.3 & 6.4)
  4. Equipment Calibration Record – Example Template
  5. Metrological Traceability (Clause 6.5)
  6. Setting Calibration Intervals – Decision Framework
  7. Externally Provided Products & Services (Clause 6.6)

  1. Review of Requests, Tenders & Contracts (Clause 7.1)
  2. Contract Review in Practice: Worked Scenario
  3. Method Selection, Verification & Validation (Clause 7.2)
  4. Method Validation Parameters – Complete Reference
  5. Sampling & Handling of Test Items (Clauses 7.3 & 7.4)
  6. Handling a Non-Conforming Sample on Receipt – Scenario
  7. Technical Records & Measurement Uncertainty (Clauses 7.5 & 7.6)
  8. Measurement Uncertainty Budget – Step-by-Step Example
  9. Reporting Results & Non-Conforming Work (Clauses 7.8 & 7.10)
  10. Statement of Conformity & Decision Rules (Clause 7.8.6)

  1. Management System Options: A and B (Clause 8.1)
  2. Document Hierarchy in a Laboratory Quality Management System
  3. Documentation & Records Control (Clauses 8.2–8.4)
  4. Document Version Control – Worked Example
  5. Risks, Improvement & Corrective Actions (Clauses 8.5–8.7)
  6. Risk Register – Practical Template & Example
  7. Internal Audits & Management Reviews (Clauses 8.8 & 8.9)
  8. Internal Audit Programme – Annual Schedule Example

  1. International Accreditation Landscape
  2. Steps to Achieve Accreditation
  3. Pre-Assessment Gap Analysis Checklist
  4. Maintaining Accreditation
  5. Common Non-Conformities at Assessment
  6. Root Cause Analysis: 5-Why Example
  7. Key Terms & Glossary (Part 1)
  8. Key Terms & Glossary (Part 2)
  9. Course Conclusion – Key Takeaways

Course Benefits

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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.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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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.

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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)


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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