GAMP 5 AI Accelerated

In this course, you will receive a thorough introduction to Good Automated Manufacturing Practice (GAMP), and we will explore where and how artificial intelligence (AI) can be used to support the process. The course is designed to provide you with targeted knowledge of GAMP 5’s methodologies and their practical application, enabling you to ensure product quality, data integrity, and patient safety.

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Who can participate?

The course is designed for engineers, technicians, chemists and other professionals in the pharmaceutical industry who work with or are users of computerized systems:
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, 1 tv, 4000 Roskilde
Danish / English

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

Prerequisites to participate

No prerequisites are required, just an interest in understanding the benefits of combining GAMP5 with AI to achieve compliance and efficiency.

Course Dates Overview

Date and time Location Language Duration Price
October 27 - 28, 2026 Confirm Knowledge Center Danish 2 days DKK 10,500 excl. VAT

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GAMP 5 AI Accelerated

This two-day course provides you with in-depth knowledge of GAMP5 methodologies combined with practical application of AI tools such as ChatGPT. You will learn how integrating AI can improve product quality, data integrity, and patient safety in your systems, and how to use the tool to create GAMP-compliant documentation.

The course material is based on GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition), published by ISPE in August 2022

Course information

Teaching method

The teaching combines theory and practice with dialog and discussions based on students' experiences and industrial practice. We encourage end-of-course evaluations to continuously improve our teaching.

Course highlights

On the course you will achieve:

Understanding GAMP 5 to create clear and measurable URSs, minimizing misunderstandings and errors.
Knowledge of software categorization and risk management.
Overview of necessary documentation and how to use it effectively.
Insights on optimizing skills and collaboration.
Practical experience with the use of AI for documentation

Course program

We will be doing exercises in AI prompting, vendor evaluation, software categorization, risk assessment, requirements specification, functional specification, traceability matrix, and test plans. Throughout the course, the instructor will guide participants through the assignments, help evaluate their responses, and offer advice on how to improve.
Introduction
Key Concepts in GAMP5
Definitions & Terms
AI Introduction: Prompting and GAMP5 in AI
Planning: VPL, SQP, software categorization, risk management, URS
Design: FS, HDS, SDS, SMDS, design review
Implementation
Verification and Testing
Reporting
Operational phase
Backup and Restore
Eudralex Annex 11 and 21 CFR Part 11
Summary

After the course

Reviewed current GAMP 5 rules and guidelines.
Learn how to create relevant documents and plan development and testing phases.
Understanding issues at different lifecycle stages and complexity levels.
The ability to manage risks related to patient safety, product quality and data integrity.
Basic knowledge of prompting that is essential for using AI.

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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