Learn AI in GxP systematically and apply it competently.
The H² Academy by QFINITY is an e-learning program for AI in GxP training with 18 modules on four levels, recorded by two trainers who have contributed to ISPE GAMP guides. Experts and teams in QA, IT and the business units across pharma and medtech learn the same terms and methods, at their own pace and with a knowledge check for each module. Three access options lead from the entry level through the leadership training to the full program with certificate.
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 full program. The time commitment for the full program is 40 to 50 hours. Of that, about 15 hours go to the narrated modules, 20 to 25 hours to reading the accompanying materials and 5 to 10 hours to assessment preparation and knowledge checks.
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Time commitment
40-50hours
- Narrated modulesabout 15 hrs
- Reading the accompanying materials20-25 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, in the full program, the final assessment on the cross-cutting topics.
- Term365days
In the full program, renewable after that. Initiate and the leadership access option run for 180 days.
- For companies10+people
Role-based learning paths, on request.
Four levels, from understanding to practice.
In the full program, you work through all four levels in this order. The leadership access option brings together selected modules for management decisions.
- 01
Initiate: foundations and key terms
You learn the key terms, typical use cases and the principles of trustworthy AI.
- 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
You assess AI initiatives in the context of the system life cycle, weigh 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
Here you learn to apply quality risk management to AI and to assess data for AI use in the life sciences. This level 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 identify obligations under the AI Act and to manage collaboration with suppliers.
- 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?
In projects, we see QA, IT and the business units use the same terms differently, and AI initiatives stall at the pilot stage. For computerized systems used in GMP activities, the current Annex 11 already requires appropriately qualified personnel. Article 4 of the AI Act additionally obliges providers and deployers to take measures for the AI literacy of their staff. The ISPE GAMP guide on AI describes a methodological approach to developing and using AI in regulated environments. The program provides a shared professional foundation for this work.
- 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
Documenting AI literacy measures
The confirmation of completion or certificate documents the knowledge checks each participant has passed. On request, companies also receive a learning progress report.
- 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 in your browser, on desktop and mobile alike.
- GDPR-compliant payment processing with 256-bit encryption
- VAT invoice, including for bookings made through your company
- 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-supported computerized systems over their life cycle. For his work on AI within ISPE, he received the 2026 Max Seales Yonker Member of the Year Award (EMEA).
Oliver Herrmann
Oliver Herrmann has advised regulated companies for more than two decades whenever quality management, validation and data integrity have to keep pace with new systems. At ISPE he contributes to GAMP guides, most recently on computerized GCP systems.
Three access options to the same program.
The Initiate entry level covers the first level of the full program. The leadership access option, Leading AI in Life Sciences, contains six modules from three levels. If you start with one of the two smaller options and upgrade later, the full amount you paid is credited toward the full program.
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4 modules, first level
Initiate
Who it's forProfessionals who take part in decisions on AI initiatives without owning the systems themselves. No IT or data science background is required.
EUR 990one-time, plus VAT- M01
- M02
- M03
- M04
- Key terms and use cases, ethics, leadership, AI literacy.
- approx. 10 to 12 learning hours
- 180-day term, 365 days with the launch offer
- Confirmation of completion with module list, in support of your measures under the AI Act
Upgrade to the full program later for an additional EUR 2,000.
Join the shortlist -
6 modules from three levels
Leading AI in Life Sciences
Who it's forLeaders in QA, IT and the business units who own and prioritize AI initiatives.
EUR 1,490one-time, plus VAT- M01
- M03
- M05
- M07
- M08
- M17
- Key terms, leadership, adoption challenges, impact on CSV, regulation, AI Act.
- approx. 15 to 18 learning hours
- 180-day term, 365 days with the launch offer
- Confirmation of completion with module list
Upgrade to the full program later for an additional EUR 1,500.
Join the shortlist -
Certificate
18 modules on four levels
Full program
Who it's forExperts who specify, validate and operate AI-supported computerized systems in the GxP environment.
EUR 2,990one-time, plus VAT- All modules with introduction, reflection and final assessment.
- 40 to 50 learning hours
- 365-day term
- H² Academy certificate
Updates during the first year included. From the second year, renewal costs EUR 750 plus VAT per year. With the launch offer, the second year is included.
Join the shortlist
Join the shortlist now for the launch offer.
All 18 modules are complete. Select your preferred access option when you join the shortlist. Booking on the learning platform opens on 1 December 2026, and you will receive the booking link by email that day.
Recorded, self-paced online training available worldwide. Content in English, with a 180- or 365-day access term. Prices in EUR, excluding VAT.
This offer is intended for companies booking for their experts and for self-employed professionals paying for their own access.
Selected access optionFull program
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. Article 4 does not require a particular certificate or a guarantee that every individual reaches a specific proficiency level. The measures must nevertheless take prior knowledge, the context of use and the people affected into account. Each access option can form part of such measures, documented by knowledge checks and a confirmation of completion or certificate.
No. The draft Annex 11 revision provides for system-specific training for everyone working with computerized systems in GMP activities, 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.
More than AI basics. Anyone who uses or evaluates AI in GxP processes needs a shared understanding of intended use, risk management, governance, supplier assessment and validation, in QA, IT and the business alike. The Initiate level therefore lays that foundation for every role. The Develop, Standardize and Optimize levels deepen that knowledge, up to generative and agentic AI.
Each module ends with a knowledge check. For Initiate and the leadership access option, we issue a confirmation of completion with a module list. The full program ends with a final assessment and the H² Academy certificate. It does not carry any external certification. On request, companies receive a report on their participants' progress.
General AI training explains the technology and its limits. In GxP environments, regulated companies must also meet what the regulations require: qualified personnel under Annex 11, quality risk management, data integrity, supplier assessment and validation of the overall system. Along the way, the 18 modules follow the ISPE GAMP Guide on AI. The modules are also useful outside GxP, for example for obligations under the AI Act.
AI in GxP at QFINITY.
Readiness Assessment for your control architecture
H² Academy by QFINITYOne curriculum for your entire organization.
For companies we design role-based learning paths, with a learning progress report. 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.
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