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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...
Advanced GMP – Biologics, Cell & Gene Therapy Manufacturing Learning Path
4.7
★★★★★
97% Recommended
Updated 2025
18 hours
156 active users
18 points
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1 x Advanced GMP – Biologics, Cell & Gene Therapy Manufacturing Learning Path
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Each course includes:
Fully compliant
This learning path is aligned with EU GMP Annex 1, ICH Q5/Q6 biologics guidance, and current ATMP regulatory frameworks — 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 Advanced GMP – Biologics, Cell & Gene Therapy Manufacturing Learning Path is designed for professionals working in advanced therapy medicinal product (ATMP) manufacturing environments. It covers the specialised GMP considerations for biologics, cell and gene therapies, viral vectors, mRNA and lipid nanoparticle products, sterile manufacturing, and contamination control.
Participants will build the specialised knowledge required to support the manufacture of complex biological and advanced therapy products in line with evolving regulatory expectations.
Courses Included
Foundational GMP considerations specific to biologic and biotech drug substance and product manufacturing.
3 hours
3 points
CMC and regulatory strategy considerations unique to cell and gene therapy products.
3 hours3 pointsManufacturing and quality considerations for viral vector, mRNA, and lipid nanoparticle-based products.
3 hours3 pointsAn introduction to the ATMP landscape, classification, and regulatory pathway.
3 hours3 pointsSterile manufacturing requirements under the revised EU GMP Annex 1, including contamination control strategy.
3 hours3 points
Building and maintaining a robust, risk-based Contamination Control Strategy across manufacturing operations.
3 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Manufacturing and QA professionals in biologics, cell and gene therapy facilities
- CMC and regulatory affairs specialists working on advanced therapies
- Sterile manufacturing and aseptic processing personnel
- Professionals transitioning from small-molecule to biologic/ATMP manufacturing
Upon completion of this learning path, participants will be able to apply GMP principles specific to biologics and advanced therapy medicinal products, understand CMC and regulatory strategy for cell and gene therapies, manage sterile manufacturing requirements under EU GMP Annex 1, and build an effective Contamination Control Strategy.
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