AI & Digitalisation in Qualification and Validation - Live Online Training
17/18 November 2026
Course No. 23115
Speakers
Ralf Gengenbach
gempex
Dr Arno Terhechte
GMP Inspectorate
Michael Wegmann
Formerly F. Hoffmann-La Roche
Dr. Clemens Borkenstein
ZETA
Christoph Neumann
Bayer
Haluk Dönmez
B. Braun
Franziska Strobel
Uhlmann Pac-Systeme
Hans Hanning
INCONSULT
- View of an EU Inspector - AI as a catalysator for validation documentation and testing? - AI and cybersecurity
Target Group
It is aimed at those interested in the use of artificial intelligence in the field of qualification and validation, but who also want to know which requirements are necessary from an official point of view before use. Explicitly addressed are e.g. quality management/quality assurance managers, validation officers, production managers, etc.
Objectives
Hardly any other topic is currently being discussed in the pharmaceutical industry as much as the use of artificial intelligence. The potential applications appear to be vast, the uncertainty even greater. So, there are a lot of questions:
Is AI allowed to be used in a GMP environment?
How can AI help to draft protocols, tests and reports?
Can AI help for a comparison of URS vs FDS
Can AI be a supporter for a traceability matrix?
What about Human in the Loop?
How to ensure data integrity with AI?
With the focus on qualification and validation the course AI & Digitalisation in Qualification and Validation aims to help clarify these questions. Also the use of electronic systems for qualification and validation activities is covered. An EU inspector will give his opinion on AI and Digitalisation in Qualification and Validation. There is also a look into AI and Cybersecurity.
Programme
State of the Art Qualification/Survey AI
Equipment Qualification in 2026 - What is state of the art
Effectiveness in Equipment Qualification
Outlook into the future – Is AI the solution? - Presentation of the results of ECA´s AI Survey
The Use of AI in Qualification – a roadmap
ECA´s Good Practice Guide Qualification and Validation
Annex AI in Qualification
EU AI act and human in the loop
Expectations to the industry
The Use of AI during the Qualification of a Particle Control Machine
Qualification of a Particle Control Machine - What is necessary
Testing and Validation
Limitations
AI as a tool to handle URS and facilitate End-2-End validation processes
AI for Validation Documentation & Efficiency
Validation Plans, Testcases, Traceability Matrices, Gap Detection
Quality vs. Speed: Quality Requirements (“Garbage in – Garbage out”)
Where to Start? Practical Entry Points for AI Adoption
What About Compliance? Regulatory Expectations and Practical Considerations
AI in Qualification and Validation – view of a GMP Inspector
AI in GMP Environments - Currently regulatory expectations and legal framework (Annex 11, Annex 22, Annex 15, FDA)
Validation of “black boxes” - How can compliance of AI systems be ensured during implementation and operation?
Practical Focus - Cloud computing as an enabler
Efficient Paperless Qualification and Validation
Status quo paper-based Qualification &Validation
Basic requirements for a lean Qualification &Validation
QMS Approach to data-orientated Objects
Automatic generated Reports and KPI´s of the systems
Outlook: AI support with HITL
Do´s and Don’t´s
Aspects of AI – Attack and Defense
State of the Art
Cybersecurity in a GMP environment
Risks and Challenges
Protective Measures
Compliance
Outlook
Further Information
Technical Requirements Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees Non-ECA Members EUR 2090.- ECA Members EUR 1890.- APIC Members EUR 1990.- EU GMP Inspectorates EUR 1045.- per delegate plus VAT The conference fee is payable in advance after receipt of invoice. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
