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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...
Quality Assurance Specialist Learning Path
4.5
★★★★★
97% Recommended
Updated 2025
18 hours
158 active users
18 points
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Each course includes:
Fully compliant
This learning path is aligned with EU GMP, ICH Q9/Q10 quality risk management principles, and FDA combination product regulations — providing comprehensive compliance coverage for the topics covered. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
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 a database, re-sitting the exam does not 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 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 Quality Assurance Specialist Learning Path develops advanced QA capabilities for professionals responsible for batch release, supplier oversight, human error investigation, and combination product quality. It builds on core GMP knowledge to address the more specialised responsibilities of experienced QA professionals.
Participants will develop the skills to manage Qualified Person responsibilities, investigate human error and performance issues, oversee suppliers and vendors, and manage the quality requirements of combination products.
Courses Included
The regulatory role of the Qualified Person and the requirements for batch certification and release.
3 hours
3 pointsInvestigating human error root causes and applying human performance principles within GxP quality systems.
3 hours3 pointsQualifying and managing suppliers, vendors, and service providers within a GxP quality framework.
3 hours3 points
Quality considerations and regulatory requirements specific to drug-device combination products.
3 hours3 pointsBest practices for record-keeping, archiving, and retention in compliance with GxP requirements.
3 hours3 points
Applying risk-based quality management principles across manufacturing and quality operations.
1 hours2 pointsOur Certified Customers
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Frequently Asked Questions
- Qualified Persons and senior QA professionals
- QA specialists managing supplier and vendor qualification
- Quality professionals working with combination products
- QA leads responsible for records management and quality risk management
Upon completion of this learning path, participants will be able to support Qualified Person batch release decisions, investigate human error using structured methods, qualify and manage suppliers and vendors, manage combination product quality requirements, and apply quality risk management principles.
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