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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...
AI & Digital Compliance in Life Sciences Learning Path
4.7
★★★★★
97% Recommended
Updated 2025
22 hours
0 active users
22 points
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1 x AI & Digital Compliance in Life Sciences Learning Path
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Each course includes:
Fully compliant
This learning path is aligned with current EU AI Act requirements, EU GMP Annex 11, EU GMP Annex 22, FDA 21 CFR Part 11, GAMP 5, and ICH guidelines, equipping learners to operate within regulated digital and AI environments in life sciences. Learners also 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 AI & Digital Compliance in Life Sciences Learning Path is designed to provide comprehensive training on the regulatory, validation, and governance frameworks shaping the adoption of artificial intelligence and digital technologies across pharmaceutical, clinical, and healthcare environments. Covering the EU AI Act, EU GMP Annex 22, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, cybersecurity, and responsible AI implementation, this programme equips professionals with the practical knowledge required to deploy, validate, and oversee AI and computerised systems in compliance with current and emerging regulatory expectations.
Participants will develop an understanding of AI risk classification and regulatory obligations, computer system validation principles, data integrity requirements, audit readiness, quality management system integration, and cybersecurity essentials — all within the context of life sciences regulatory frameworks. The programme also covers the practical application of AI in pharmacovigilance, clinical research, and pharmaceutical manufacturing, preparing professionals for a digitally transformed industry.
How this differs from the individual AI in Healthcare and Pharmaceuticals courses
The AI & Digital Compliance in Life Sciences Learning Path takes a broad compliance-first approach, combining AI governance, computer system validation, data integrity, electronic records regulations, and cybersecurity into a single structured programme. It is designed for professionals who need end-to-end competency across the digital and AI compliance landscape in regulated environments.
In comparison, the individual AI in Healthcare and Pharmaceuticals courses focus more specifically on the practical implementation, responsible use, and QMS integration of AI tools. This learning path is best suited to regulatory affairs specialists, quality professionals, IT validation teams, and digital transformation leads who require both strategic oversight and operational compliance knowledge.
Courses Included
Core AI concepts, validation frameworks, and responsible deployment practices across healthcare and pharmaceutical settings
3 hours
3 points
Ethical AI use, bias management, transparency requirements, and compliance with global regulatory expectations for AI-driven healthcare tools
3 hours3 points
Practical AI implementation strategies, integration with quality management systems, and preparing for regulatory inspections involving AI
3 hours3 points
Annex 11 requirements for computerised systems, audit trail management, and inspection readiness for regulated IT environments
3 hours2 pointsAI applications in adverse event case processing, signal detection, and literature screening — forward-looking competency for PV professionals
2 hours3 pointsOur Certified Customers
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Frequently Asked Questions
- Regulatory Affairs and Quality Assurance professionals in pharmaceutical and life sciences organisations
- Computer System Validation (CSV) and IT compliance teams
- Digital transformation leads and innovation managers in regulated industries
- Clinical data managers and clinical operations professionals
- Pharmacovigilance and drug safety professionals adopting AI-driven tools
- GMP, GCP, and GVP compliance officers overseeing computerised systems
- Healthcare IT professionals working within regulated environments
- Life sciences graduates and professionals seeking expertise in AI compliance and digital regulation
- Professionals preparing for regulatory inspections involving AI or computerised systems
Upon completion of this learning path, participants will be able to understand and apply the key regulatory frameworks, validation methodologies, and governance principles governing AI and digital systems in life sciences — including the EU AI Act, EU GMP Annex 22, GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and cybersecurity requirements — enabling them to support compliant implementation, validation, and oversight of AI and computerised systems across pharmaceutical, clinical, and healthcare environments.
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