GAMP 5 AI Power Day

In this one-day course, we’ll use AI to work our way through the entire GAMP5 V-model. GAMP is widely recognized and used in the pharmaceutical industry, but how can artificial intelligence be best utilized to assist us?

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Who can participate?

The course is aimed at pharmaceutical industry professionals with existing knowledge of GAMP5, including:
Automation and IT engineers
Project engineers and managers
QA employees and managers
IT managers
Process technicians and chemists
Machine builders and robot suppliers

Course overview

Confirm Knowledge Center
Havnevej 1 1tv. 4000 Roskilde
Danish / English

The teaching material will be in English.
Teaching will be in Danish.

Prerequisites to participate

Participants are expected to have previously completed a GAMP5 course or have equivalent experience with GAMP5 principles.

Course Dates Overview

Date and time Location Language Duration Price
December 15, 2026 Confirm Knowledge Center Danish 1 day DKK 5,500 excl. VAT

Read more about the course

GAMP 5 AI Power Day

This intensive one-day refresher course is tailored for former participants in GAMP 5 courses as well as experienced professionals working in the validation of IT and automation systems. The course provides a practical and up-to-date introduction to how modern AI tools such as ChatGPT can be used to streamline documentation, testing, and validation in accordance with GAMP 5.

The course material is based on ISPE’s GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) from 2022 and the Artificial Intelligence Guide from 2025, as well as reflection papers from the EMA and FDA.

Course information

Teaching method

The training combines theory with practical examples and exercises based on industrial practice. We encourage continuous dialog and sharing of experiences to increase understanding and learning. At the end of the course, we always ask for student evaluation to ensure continuous improvement.

Course highlights

On the course you will achieve:

Insights into how AI can transform traditional GAMP5 processes and increase efficiency.
Hands-on experience using ChatGPT to create and optimize GAMP5 documentation.
Understanding the new AI-related additions in GAMP5's second edition.
Knowledge of how AI can be used for risk management and supplier evaluation within the GAMP5 framework.

Course program

Good AI Prompting
GAMP5 Appendix on AI
GAMP Artificial Intelligence (ISPE Guide)
EMA AI Reflection Paper
FDA AI Consideration Paper
EU Annex 22
Challenges in Using AI (Validation)
V-Model using AI – document creation: o Risk assessment o URS o Specifications o Test

After the course

Implement AI tools into your existing GAMP5 processes to improve efficiency and accuracy.
Create and review documentation using AI, reducing time and increasing accuracy.
Use AI to identify and manage risks and evaluate suppliers in accordance with GAMP5 principles.

Instructors on the course

Jeppe Lunde Schmidt

Validation specialist at Confirm with extensive experience in implementing and validating IT systems in the pharma sector. Jeppe brings practical examples and cases into the training to ensure relevance and applicability.

Katrine Rivière

Engineering Manager at Confirm with in-depth experience in both GAMP5 and AI applications in the pharmaceutical industry. Katrine is recognized for her ability to communicate complex topics in an understandable and practical way.

Testimonials from learners

Course participant in Introduction to GAMP 5
Really good and professionally strong presentation. The trainer found the right professional level for the group and initiated good tasks and resulting discussions. And super with small breaks every hour.
Course participant in Introduction to GAMP 5
Many thanks and much praise to Katrine! As a teacher, you are present, relevant, a skilled communicator and very pleasant. You manage to bring your experience from both teaching and practice into play in the context in which we ask the questions.
Course participant in Introduction to GAMP 5
I think it was good to mix the theory and the practical part. The teacher was super good at explaining and super good at pulling out examples that supported the theory.
Course participant in Data Integrity
The benefit of the course is a quick and processed approach to the ISPE guide.
Course participant in Data Integrity
It was a great course that lived up to all expectations. Super good teacher 🙂
Course participant in Data Integrity
Really good course... even after many hours you are still in it... course leader can maintain focus and interest
Student in SattLine Programming
A good structure of course material and balance between theoretical material and exercises. The theoretical parts gives food room for more in depth questions of interested.
Student in SattLine Programming
Very motivated course-responsible, very pationate and patient.
Course participant in Data Integrity
Good with exercises and quizzes. Good location and delicious food/catering.
Student in SattLine Programming
Super teacher 👍😁

Do you have any questions?

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