Ralf Gengenbach
gempex
Referierende
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
Zielgruppe
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.
Zielsetzung
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.
Programm
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
Weitere Informationen
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.
Contacts
Questions regarding content:
Mr Sven Pommeranz, +49 6221 84 44-47, pommeranz@concept-heidelberg.de
Questions regarding organisation:
Mrs Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 17 November 2026, 09:00-16:30 h
Wed, 18 November 2026, 08:30-12:45 h
All times mentioned in CET
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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