Basics of AI in a GxP Environment - Live Online Training
Tuesday, 9 February 2027 9 .00 - 18.00 h
Course No. 23269
Speakers
Stefan Münch
Körber Pharma Consulting
Yves Samson
Kereon
Daniel Santak Wolf
Ulm University Hospital
Highlights
- The Importance of Data and Models
- Differences between General Purpose AI and Spezialised AI
- Risk Management and Validation in AI
Target Group
The Live Online Training is aimed at
Managers and interested parties from the pharmaceutical industry
Suppliers
Service companies
who want to find out more about the basics of AI and its possible applications in the pharmaceutical Environment.
Objectives
What can you expect in the Live Online Training?
Get to know the basics of AI (Artificial Intelligence) and ML (Machine Learning),
Learn about the importance of data and models,
Understand the difference between specialised AI and generative AI,
Risk management and validation; how should these classic pharmaceutical topics be considered and applied in the context of AI and
What are the applications and limitations in the GxP environment? Learn about the current state of development.
Programme
Introduction to Artificial Intelligence (AI) and Machine Learning (ML)
History of AI
Types of AI
Current situation and real-life examples
Technological Basics
Different learning / training Methods
Example use cases
Data and Models
Overview of core model architectures and data types
Data splitting: training, validation, and testing phases
Ensuring data quality, representativeness, and overcoming common bottlenecks
Specialised AI: How Task-Specific Models Work
Specialized vs. General-Purpose AI: Understanding the key differences
Step-by-step training process, using cancer diagnostics as a case study
The roles of pre-training and fine-tuning
Ensuring AI traceability and explainability in critical Tasks
General-Purpose AI: How Generative Models like GPT & Co. Work
Fundamentals of Large Language Models (LLMs)
Strengths and limitations of LLMs compared to specialized AI
Introduction to LLMs acting as autonomous agent
Risk Management / Validation for AI/ML Solutions
Applying ICH Q9 QRM to AI/ML
QRM throughout the System Life Cycle
Thinking critically about AI-enabled Computerized Systems
Using the AI Maturity Model
Achieving Data and Model Governance
Overview of AI/ML in Pharmaceuticals, Biotech and Medical Devices
Challenges facing the life sciences industry in dealing with AI and ML
GAMP® 5 meets AI: The GAMP AI Guide
Use cases for AI in pharma and biotechGMLP (Good Machine Learning Practice): An SDLC for AI/ML
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events 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.
Fees (per delegate, plus VAT)
ECA Members EUR 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,290 EU GMP Inspectorates EUR 645 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate 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.
Conference language The official conference language will be English.
Testimonials
