Introduction to GAMP 5

How to optimize the quality and time spent developing your computerized systems by using Good Automated Manufacturing Practice (GAMP). This course is designed to provide you with targeted knowledge of GAMP 5 methods and their practical application to ensure product quality, data integrity and patient safety.

Sign up for a course Read more about it

Who can participate?

The course is for engineers, technicians, chemists and others who work with or are users of computerized systems in the pharmaceutical industry:
Automation and IT engineers.
Project engineers and managers.
QA employees and managers.
IT managers.
Process engineers and chemists.
Machine builders and robot suppliers.

Course overview

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

Prerequisites to participate

There are no prerequisites other than an interest in understanding how GAMP as a tool can benefit suppliers of automated systems that must comply with current GMP regulations.

Course Dates Overview

Date and time Location Language Duration Price
October 5–7, 2026 Online, 1:00–5:00 PM (CEST / UTC+2) English language 3 days
, 4 hours per day		 8,500 DKK, excluding VAT
November 4 - 5, 2026 Confirm Knowledge Center English language 2 days DKK 10,500 excl. VAT
December 9–10, 2026 Confirm Knowledge Center Danish 2 days DKK 10,500 excl. VAT

Read more about the course

Introduction to GAMP 5

Good Automated Manufacturing Practice (GAMP) provides a logical and systematic approach to categorizing, documenting and risk assessing automated systems. In this course, you will gain targeted knowledge on how GAMP 5 methods can help you ensure that product quality, data integrity and patient safety are in order in your computerized systems. The course material is updated with content from the 2nd edition of GAMP5 A Risk-Based Approach to Compliant GxP Computerized Systems published by ISPE in August 2022. Computer System Validation (CSV) is becoming an increasingly important part of the pharmaceutical industry as more production is managed digitally.

Course information

Teaching method

The teaching is a mix of theory and practice, with dialog and discussions based on both student experience and industrial practice. We are always striving to improve our courses and therefore encourage evaluations at the end.

We will be doing exercises in supplier evaluation, software categorization, risk assessment, and requirements specification. The instructor will guide the participants through the exercises, help evaluate their responses, and offer advice on how to improve.

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.

Course program

Introduction
Key Concepts
Definitions & Terms
Concept Phase
Project Phase
Life Cycle Approach
Planning: VPL, SQP, software categorization, risk management, URS
Design: FS, HDS, SDS, SMDS, design review
Implementation
Supplier Activities
Verification & Testing
Reporting
Operational phase
Backup and Restore
Decommissioning
New appendices in the 2nd edition
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.

Instructors on the course

Katrine Rivière

In addition to teaching, Katrine works as Engineering Manager at Confirm. Her interest in sharing methods and concrete tools is based on Katrine's own experience as a consultant in the pharmaceutical industry. The course participants particularly value her ability to understand customers' problems, as well as her ability to make complex problems concrete and show examples of how to solve them operationally.

Jeppe Lunde Schmidt

Jeppe works in our validation team on a daily basis. He has GMP experience from several large remodeling projects in pharmaceutical packaging plants and countless validations of everything from simple transmitters to large complex IT systems. He has produced and read a wide variety of documentation and has visited companies and sites across the country. He has worked with manufacturers of both pharmaceuticals and medical devices and incorporates his experience in the industry into his teaching. Jeppe has several years of teaching experience and teaches several of our other courses, including GAMP5 and Data Integrity.

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?

Contact us

If you have any questions regarding our courses, we are ready to help you. Write to us