Dr Simon Schäfermann
Regierungspräsidium Tübingen
Referent:innen
Rolf Blumenthal
Selbstständiger Berater
Manfred Karner
Takeda
Philip Lienbacher
Takeda
Torsten Kneuss
Bayer
Peter Hackel
Takeda
All times mentioned are CET.
Hintergrund
In this seminar, you will learn about the possibilities of using artificial intelligence in the areas of quality assurance and quality control in the pharmaceutical Industry.
You will learn
You will learn
- How GPT can be used for daily work with GMP documents
- How processes can be automated with the help of AI and digital tools
- Which prompting techniques lead to good results
- How AI can be used in pharmaceutical quality control
- What support AI applications can provide for batch release
You will also receive the latest information from ISPE’s new GAMP AI Good Practice Guide.
Now that the use of artificial intelligence in medical diagnostics has already found its way into the field of imaging procedures, the use of AI applications in the GxP environment is expanding rapidly. Specifically defined chatbots can be used, for example, to search for information on websites. Specially trained GPTs provide support in handling GMP-regulated documents such as qualification/validation documents, stability protocols or trend Reports.
Zielgruppe
This seminar is aimed at those responsible in the areas of quality assurance and quality control in the pharmaceutical industry who use AI applications in their areas or decide on their use.
Date & Technical Requirements
Date of the Live Online Training
Tuesday, 17 February 2026, 9.00 – 17.00 h
Wednesday, 18 February 2026, 8.30 – 14.30 h
All times mentioned are CET.
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Use of AI in the GxP Environment from a GMP Inspector’s Perspective
- EU GMP Guideline Annex 11
- Concept Paper Revision of Annex 11
- EMA Reflection paper on the use of Artificial Intelligence (AI)
- Guidelines from the pharmaceutical world
- Inspection practice
Use of AI in the GxP Environment - what is Required to Generate the Necessary Trustworthiness
- Potentials and challenges in the use of AI in the pharmaceutical industry
- Current laws and guidelines on AI
- Some important AI terms and concepts
- Data are the true indicators of Performance
- What role do humans play and what roles are required?
- From the use case to the right AI system, validation of AI application using a life cycle model
- Risk and quality management
- Briefing on ISPE’s GAMP AI Guideline
Generative Pre-Trained Transformer (GPT) - Use in the Pharmaceutical Industry
- Potential applications
- Benefits and challenges
- Training and working methods of a GPT
- Regulatory aspects
- Integration into the corporate application landscape
- Use of platforms
- Use of own data sources to increase fact security (RAG: Retrieval Augmented Generation)
- Steering GPT systems in the right direction (Guardrails)
Use of AI and Digital Tools to Support Daily QA Work
- Digital Transformation – a journey
- Use of GPT (Generative Pre-trained Transform) - (ChatGPT, MS Copilot)
- Automated creation of documents/presentation
- Translations / rewording of Texts
- Use suggestions from Chat GPT, e.g. to define CAPA measures
- Document analysis with GPT
- Summarizing and extracting key information from multi-page reports (e.g. FDA 483s, guidelines)
- Creation of meeting notes based on meeting transcripts and extraction of action items
- ChatBots or user-defined GPT applications
- Creation of GPT-ChatBots for information
- Searching authorities’ sites to obtain Information
- Search for references to audit observations specifically in the online versions of guidelines
- Assistance on questions about process from process instructions, work instructions
Digitalization/Automation as the Basis for the Efficient Use of AI in QA and QC
- Basics for QC & QA on IT framework - digitalization - automation - use of AI
- Generation of raw data and data systems
- Real-life automation examples QA & QC
Application Examples for AI in QA - from the Idea to Use
- Collection and benefit assessment of AI use cases
- Development of solutions
- Automation Pipelines
- No-code/low-code tools
- Application examples in QA
- Audit Management
- Complaint Management
- Deviation management
- Quality management documentation
Digitalization/Automation and AI in QA
- Application examples Batch release
- Batch tracking & visualization
- Authority documents
- Cooperation between QA and production
- GEMBA and GMP tours: automation example
Automation of Processes Using AI and Digital Tools
- Microsoft Power Platform
- Creation of applications and automations without in-depth programming Knowledge
- Connection of AI elements with self-created applications and automations
- Data Correctness – key for success
- Automation of tracking and managing processes (Audit process as an example)
- Using machine learning to automatically extract information from pdfs - Supplier Notification of Change (SNC) as example
- GPT support for processing SNCs
- Translation of documents transmitted in the respective national language
- Support in the classification of SNCs in terms of criticality through AI recommendations
- Use of GPT for the automatic generation of audit reports based on notes
Basics of Prompt Engineering
- Introduction ChatGPT
- Introduction to prompt engineering
- Prompt techniques
- Zero-shot prompting, few shot prompting
- Chain-of-Thought
- Reverse engineering prompting
- Risks and misapplications
Use of AI in QC – Guidelines
- QA processes and their specific needs
- Step by step approach for automation/digitalization
- Use-Cases of AI and Automation in QC
- GPTs in QC for protocols, reports and qualification/validation documents
- Investigation reports, stability protocols, qualification of equipment or standards, method validation, method transfer, responses to authorities
- What are the basics of the use/application case?
- KPI review and trend reports
From Data Generation to Use - Opportunities and Potential Pitfalls of Digitalization
- Responsibility: Why data governance starts with the business process
- System architecture: How we can make data usable and why one way is not always the right way
- Data quality and integrity: Use of data in the GxP environment and how we can ensure trust in our data
- Utilization: Systematic and sustainable implementation of digital tools, also through citizen development.digital tools, also through citizen development
| 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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E-Mail: info@concept-heidelberg.de
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