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Laboratory Auditing: ISO/IEC 17025, GLP, GCLP and GMP Quality Control Laboratories Course & Certification
Intermediate
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3 hours
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Laboratory Auditing: ISO/IEC 17025, GLP, GCLP and GMP Quality Control Laboratories
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About
Laboratory Auditing: ISO/IEC 17025, GLP, GCLP and GMP Quality Control Laboratories training provides a comprehensive understanding of auditing principles and practices applicable to regulated laboratory environments. It equips learners with the knowledge to assess laboratory quality systems, evaluate compliance, identify risks, and perform effective audits across testing, calibration, non-clinical, clinical trial, and pharmaceutical quality control laboratories.
This Laboratory Auditing Certification Course provides essential knowledge on audit principles, risk-based audit planning, audit preparation and execution, evidence collection, data integrity assessment, laboratory documentation, equipment qualification, method validation, CAPA evaluation, and inspection readiness. The course covers key regulatory frameworks including ISO/IEC 17025 laboratory competence requirements, OECD GLP principles, WHO GCLP expectations for clinical trial laboratories, and GMP quality control laboratory requirements. Upon successful completion, learners receive a certification demonstrating their understanding of laboratory auditing practices and compliance expectations across regulated laboratory environments.
Who Should Enrol?
- Laboratory Auditors and Quality Assurance Professionals
- QC Laboratory Managers, Supervisors, and Analysts
- GMP Quality Control and Pharmaceutical Laboratory Personnel
- ISO/IEC 17025 Laboratory Professionals and Technical Staff
- GLP and GCLP Compliance Professionals
- Internal Auditors and Regulatory Compliance Teams
- Validation, Data Integrity, and Documentation Specialists
- Pharmaceutical, Biotechnology, Clinical Research, and Contract Laboratory Personnel
- Anyone responsible for laboratory quality systems, audits, and regulatory compliance
What you will learn
Understand the principles of laboratory auditing, audit planning, execution, and reporting within regulated laboratory environments.
Learn the requirements and expectations of ISO/IEC 17025, OECD GLP, WHO GCLP, and GMP quality control laboratory frameworks.
Develop knowledge of risk-based auditing, laboratory documentation, data integrity, equipment qualification, method validation, sample management, and compliance assessment.
Gain understanding of audit evidence collection, findings classification, CAPA evaluation, root cause analysis, inspection readiness, and best practices for maintaining effective laboratory quality systems.
Course Syllabus
- Why laboratory audits matter and the course scope
- The four frameworks: ISO/IEC 17025, OECD GLP, WHO GCLP and GMP QC
- Audits versus inspections versus accreditation assessments
- The audit lifecycle and risk-based auditing
- Auditor responsibilities and evidence-based findings
- The Veritas case study, assessment structure and certification
- Why laboratories are audited, and what an audit is and is not
- First-, second- and third-party audits; internal and supplier audits
- The seven ISO 19011 audit principles
- Audit terminology and audit criteria
- Cross-framework auditing: 17025, GLP, GCLP and GMP QC
- Auditor competence, technical experts and conflicts of interest
- The audit programme and its objectives
- Risk-based scheduling and frequency
- Auditor selection and the individual audit
- Preparation: documents, plan, sampling and logistics
- The end-to-end laboratory process and process mapping
- Auditing each stage: request to disposal
- Tracing: forward, backward, horizontal and vertical
- Sample-to-report, report-to-raw-data and other traces
- Facilities, environment and contamination control
- Equipment lifecycle, qualification, calibration and maintenance
- Traceability, reference standards, reagents and media
- Methods, validation, verification, transfer and specifications
- Proficiency testing, interlaboratory comparison and competence
- Technical records, calculation and measurement uncertainty
- Data-integrity foundations: ALCOA+, records and metadata
- Laboratory computerised systems and validation status
- Access control, electronic signatures and audit trails
- Data processing, reintegration and reprocessing
- Backup, restore, archive and hybrid records
- Cloud systems, supplier access and cybersecurity
- Opening the audit and communicating
- Interviewing, observing and reviewing evidence
- Following trails and managing difficult moments
- Team review, remote and hybrid conduct, and closing
- From evidence to classified outcomes
- Constructing and grading findings
- Conclusions, the closing meeting and the report
- CAPA: correction, root cause and action
- Effectiveness, follow-up, closure and trending
- One methodology, four frameworks
- Auditing an ISO/IEC 17025 laboratory
- Auditing an OECD GLP facility
- Auditing a WHO GCLP laboratory
- Auditing a GMP quality-control laboratory
- Framework application activities
- Recap of the plan-prepare-conduct-report-follow-up methodology
- Keeping framework criteria and sources distinct
- Evidence-based findings and CAPA effectiveness
- Final assessment and certificate of completion
- 📘 Bonus:Laboratory Auditing 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 changes to ISO/IEC 17025:2017, ISO 19011:2026, the OECD Principles of Good Laboratory Practice, WHO Good Clinical Laboratory Practice guidance, and EU and FDA GMP quality-control laboratory guidance, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by practitioners with laboratory-audit and quality-assurance expertise across ISO/IEC 17025, GLP, GCLP and GMP QC environments, so that learners can plan, conduct and follow up laboratory audits with confidence at the bench and in the quality system.
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