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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
GCP Inspection & Audit Readiness Learning Path
4.4
★★★★★
94% Recommended
Updated 2025
16 hours
188 active users
16 points
If you'd like to swap a course or add additional courses, simply let us know — Reach out to us and we’ll customize a learning path tailored to your training needs.
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1 x GCP Inspection & Audit Readiness Learning Path
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Each course includes:
Fully compliant
This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded 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.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The GCP Inspection & Audit Readiness Learning Path is designed to help clinical research professionals build the knowledge and practical skills required to prepare for, manage, and successfully navigate GCP inspections and audits. This comprehensive programme covers key areas including ICH GCP E6(R3) requirements, inspection readiness strategies, documentation and data integrity expectations, Trial Master File (TMF) management, CAPA processes, informed consent compliance, sponsor and site responsibilities, and effective communication during regulatory inspections and audits.
Participants will gain a practical understanding of how to identify compliance gaps, maintain inspection-ready records, support audit activities, and respond confidently to regulatory authorities, sponsors, and CROs. The learning path also focuses on fostering a culture of quality, risk management, and continuous improvement across clinical trial operations.
Who Should Enrol?
- Clinical Research Associates (CRAs), Clinical Trial Coordinators, and site staff involved in clinical trial conduct.
- Quality Assurance, compliance, TMF, document management, and audit support professionals.
- Principal Investigators, Sub-Investigators, sponsors, CRO personnel, and clinical operations teams.
- Regulatory affairs professionals and individuals involved in inspection and audit preparation activities.
What you will learn
Understand the fundamentals of GCP inspections and audits, including regulatory expectations under ICH-GCP E6(R3) and global compliance standards.
Learn how to maintain inspection-ready Trial Master Files (TMFs) and ensure complete, accurate, and audit-ready clinical documentation.
Develop skills to identify compliance gaps, apply CAPA (Corrective and Preventive Action) processes, and uphold data integrity in clinical trial activities.
Gain practical knowledge to prepare for regulatory inspections and sponsor audits, manage findings effectively, and ensure continuous quality improvement.
Courses Included
Core audit methodology — planning, execution, findings classification
1 hours
2 points
Responding to inspection findings; root cause analysis and CAPA writing
2 hours3 points
Gain an understanding of Quality Management System principles and their application within clinical research sites.
2 hours3 points
Joint GCP/GMP inspection preparation — FDA, EMA, MHRA approaches.
2 hours3 points
Standalone CAPA module for QA professionals
1 hours3 points
Auditors must know E6 R3 to assess site compliance against new standard
3 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Clinical Research Associates (CRAs)
- Clinical Trial Coordinators and Site Staff
- Quality Assurance and Compliance professionals
- Principal Investigators and Sub-Investigators
- Sponsors, CRO personnel, and Clinical Operations teams
- Regulatory Affairs professionals
- TMF, document management, and audit support teams
- Professionals involved in inspection and audit preparation activities
Upon completion of this learning path, participants will be able to prepare for and support GCP inspections and audits, maintain inspection-ready documentation and TMFs, identify and address compliance gaps, apply CAPA and data integrity principles, and confidently manage regulatory and sponsor audit expectations in alignment with ICH GCP E6(R3) requirements.
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