Learn AI in GxP systematically and apply it competently.
The H² Academy by QFINITY delivers AI in GxP training as one continuous e-learning program, from key terms to operating AI-enabled systems. It is aimed at individuals and entire teams in QA, IT and the business units across pharma and medtech. You learn at your own pace, with a knowledge check for each module and a final assessment.
The H² Academy launches on
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What does the AI in GxP e-learning program include?
The AI in GxP Enablement Training Program of the H² Academy comprises 18 core modules on four levels, framed by an introduction and a closing reflection. Each module consists of a narrated presentation, a learning letter and a knowledge check. A final assessment on the cross-cutting topics concludes the program. Together with the 18 knowledge checks, that makes 19 assessments. The 18 learning letters run to more than 400 pages. The time commitment is 40 to 50 hours. Of that, about 15 hours go to the narrated modules, 20 to 25 hours to reading and 5 to 10 hours to assessment preparation. Access lasts 365 days and can be renewed. Companies book packages for teams of 10 or more. These include reporting on learning progress and trainer-led sessions.
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Time commitment
40-50hours
- Narrated modulesabout 15 hrs
- Reading the learning letters20-25 hrs
- Assessment preparation and knowledge checks5-10 hrs
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Curriculum
18core modules across four levels
- Initiate4
- Develop4
- Standardize5
- Optimize5
- Learning material18learning letters
More than 400 pages, for desktop and mobile devices.
- Evidence19assessments
One knowledge check per module and a final assessment on the cross-cutting topics.
- Access365days
You can renew after that. For companies, the agreed term applies.
- For companies10+people
Packages with reporting and trainer-led sessions, on request.
Four levels, from understanding to practice.
Each level builds on the one before, from key terms to operating AI-enabled systems. The list under each level shows which modules belong to it.
- 01
Initiate: foundations and key terms
You learn the key terms, typical use cases and the principles of trustworthy AI. That builds the AI literacy that Article 4 of the AI Act requires providers and deployers to promote.
- M01Key Terms and Use Cases
- M02Ethical Principles and Trustworthy AI
- M03Leading AI in Life Sciences
- M04Foundational Artificial Intelligence Literacy
- 02
Develop: life cycle and regulation
At this level you place AI initiatives in the system life cycle, assess their effect on CSV activities and gain an overview of the regulatory landscape from the AI Act to the draft Annex 22.
- M05Common Challenges of AI Adoption
- M06Development Approach and System Life Cycle
- M07Dual Impact of AI on CSV Activities
- M08Overview of the AI Regulatory Landscape
- 03
Standardize: quality, data, roles
This level covers quality risk management for AI and data for AI in the life sciences. It also teaches you to specify, verify and document a model and to define roles and responsibilities clearly.
- M09Quality Risk Management
- M10Quality Management and the Role of Quality
- M11Data for AI in Life Sciences
- M12Specification, Verification and Documentation
- M13Roles, Responsibilities and Knowledge Management
- 04
Optimize: operations, security, suppliers
Finally, you assess infrastructure, cloud services and cybersecurity in an AI context and put generative and agentic AI in perspective. You also learn to manage supplier collaboration in line with the AI Act.
- M14Infrastructure, Platforms and AI Cloud Services
- M15Cybersecurity in an AI Context
- M16Generative and Agentic AI
- M17European Artificial Intelligence Act
- M18Supplier Collaboration and Management
Why does the use of AI in GxP need a shared frame of reference?
Each function knows its job. Quality, IT and the business units often lack a common frame of reference for joint decisions. In projects we see teams talk past each other and AI initiatives stall at the pilot stage. Three texts shape that frame. Article 4 of the AI Act obliges providers and deployers to take measures for the AI literacy of their staff. The draft Annex 22 provides for adequate qualification and defined responsibilities for everyone involved. The GAMP guide on AI offers the methodology for it. The program defines terms that mean the same thing to everyone. That ranges from intended use through model verification to Human Oversight. Teams can then assess and introduce new processes and technologies together.
- 01
The same terms
Everyone involved learns from the same curriculum on the life cycle, quality risks and responsibilities, and makes decisions on common ground.
- 02
Understanding opportunities and limits
The program shows what AI is suited to in GxP and where its use depends on specific conditions, such as data quality, explainability and Human Oversight.
- 03
Leadership and governance
Managers and executives learn to steer the use of AI through governance committees, an AI maturity assessment and a prioritized portfolio of use cases.
- 04
Demonstrating AI literacy under the AI Act
For your AI literacy measures under Article 4 of the AI Act, each participant's record serves as evidence of what they have learned. On request, companies also receive a report on learning progress.
- 05
Verifying the AI subsystem, validating the system
Participants learn to verify the AI subsystem against its specification and to validate the overall system against its intended use as part of their CSV practice.
- 06
Putting the regulations in context
You will be able to distinguish between what the AI Act requires, what the draft Annex 22 provides for and what methodology the GAMP guide on AI offers. This includes what the Annex 22 draft recommends on collaboration between the business, QA, data science and IT.
An e-learning program with knowledge checks and a training record.
The H² Academy runs on a learning platform from a Berlin-based provider. You learn in the browser, on desktop and mobile alike.
- GDPR-compliant payment processing with 256-bit encryption
- VAT invoice, including for bookings made through your company
- Questions for the trainers via the platform
- Updates when new guidance is published, such as the final version of Annex 22
H² Academy by QFINITY
Participants who pass all knowledge checks and the final assessment receive a personal H² Academy certificate stating the program and the completion date. Companies can add it to their training records. It is a training record, neither an ISPE certification nor evidence that your systems are compliant.
Trainers who have contributed to the industry's guides.
Both have contributed to ISPE GAMP guides and know AI in GxP first-hand from projects and audits.
Martin Heitmann
Martin Heitmann works at the intersection of digitalization, quality and innovation in the regulated life sciences. As co-lead he helped shape the ISPE GAMP Guide: Artificial Intelligence, which covers AI-enabled computerized systems over their life cycle.
Oliver Herrmann
Oliver Herrmann has advised regulated companies on quality management systems, validation and compliance for more than two decades. At ISPE he contributes to GAMP guides, most recently on computerized GCP systems.
Individual access or a package for your team.
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Individual access
For individual learners
For whomLife sciences professionals in quality, compliance, data science, IT and business units, as well as project managers, validation experts and consultants.
EUR 3,000one-time, plus VATYou receive the entire program with narrated modules, learning letters and knowledge checks. This offer is intended exclusively for companies booking for their specialists and for self-employed professionals booking in their own name.
- Access to the entire program for 365 days
- All updates during the first year
- Questions for the trainers via the platform
- Personal certificate
- From the second year, optional renewal for EUR 750 plus VAT, with continued access and all updates
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For teams
Companies
Company-wide training
For whomPharmaceutical and biotech companies, medical device manufacturers, CDMOs, CROs as well as technology and platform providers.
On requestpackages for 10 or more peopleYour team receives volume pricing and learns individually or together as a cohort. Smaller teams book individual access for each member.
- Participant onboarding
- Role-based learning paths
- Trainer-led sessions, remote or on site
- Reporting on participants' learning progress
- Integration with your learning management system
- A dedicated point of contact
Frequently asked questions about the H² Academy.
Article 4 of the AI Act, as amended by the Digital Omnibus (Regulation (EU) 2026/1744), requires providers and deployers of AI systems to take measures that promote AI literacy among their staff. The AI Act prescribes neither a specific level nor a certificate. The program is one such measure, documented through knowledge checks and the certificate.
No. The draft Annex 11 revision provides for system-specific training for everyone involved, matched to their tasks and access rights. The program creates a shared understanding of AI in GxP. Training on your specific system then builds on it.
No IT or data science background is required. With individual access, you work through the four levels in order, starting at Initiate with key terms and foundational AI literacy. Develop, Standardize and Optimize then go deeper into the life cycle, verification and infrastructure. For teams we assemble role-based learning paths. Learning letters, narrated modules and knowledge checks are in English.
Each module ends with a knowledge check, and a final assessment tests the cross-cutting topics of all modules. Participants who pass both receive the H² Academy certificate as a training record. No external certification is attached to it. On request, companies receive a report on their participants' learning progress.
Access ends unless you renew it. Renewal costs EUR 750 per year plus VAT. Renewal also includes the updates we add for new regulatory developments, for example once Annex 22 is finalized. For companies, the team package sets the term.
AI in GxP at QFINITY.
H² Academy by QFINITYOne curriculum for your entire organization.
For companies we design role-based learning paths, with trainer-led sessions and reporting. In a free intro call (about 30 minutes) we discuss team size, timeline and how to onboard your participants. You will receive a reply within one working day.
Request a team quote
