GAMP 5 for suppliers

With GAMP, your company and employees can better meet the expectations that pharmaceutical manufacturers have of suppliers of computerized systems. At the same time, you gain insights that can help you understand and engage with your customers.

Who can participate?

The course is for engineers, technicians, chemists and others who work in companies that supply the pharmaceutical industry with machinery and equipment containing computerized systems.
Automation and IT engineers
Project engineers and managers
QA employees and managers
IT managers
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

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
November 18 - 19, 2026 Confirm Knowledge Center Danish 2 days DKK 10,500 excl. VAT

Read more about the course

GAMP 5 for suppliers

GAMP is a recognized and widely used approach in the pharmaceutical industry that ensures a logical and systematic approach to the categorization, documentation, and risk assessment of automated systems. Our course focuses specifically on how you, as a supplier, can meet the requirements and expectations of pharmaceutical manufacturers by ensuring product quality, data integrity, and patient safety in the systems you provide.

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, and is designed with a focus on the supplier’s role and contribution to a computerized system.

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.

We will be doing exercises on supplier evaluation so you can get an idea of how pharmaceutical companies view you as a supplier, as well as on software categorization, risk assessment, understanding requirements specifications, the content of supplier documentation, and good documentation practices.

Here, the instructor will guide the students through the assignments, help evaluate their responses, and offer advice on how to improve.

Course highlights

On the course you will achieve:

Understanding GAMP 5 to avoid misunderstandings and misinterpretations.
Knowledge of software categorizations, documentation requirements and risk management.
Insight into customer expectations for design specifications and documentation quality.

Course program

Introduction
Key Concepts
Definitions & Terms
Concept Phase: Supplier Assessment (Content of Supplier Audit); SQP
Project Phase
Life Cycle Approach
Planning
Design: FS, HDS, SDS, SMDS, design review
Implementation
Verification & Testing
Supplier Best Practices
Good Documentation Practice (GDP)
Supplier Activities
New appendices in the 2nd edition relevant to suppliers
Summary

After the course

Have an overview of applicable GMP rules and guidelines.
Have the skills to plan, develop and test systems in accordance with requirements
Understand risk management in relation to patient safety, product quality and data integrity.
Do you have the ability to meet customer expectations for automation best practices.

Instructors on the course

Jeppe Lunde Schmidt

Jeppe works in our validation team on a daily basis and has been teaching for several years. He has worked with and validated several different types of IT equipment, from simple transmitters to large complex IT systems.

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.

Testimonials from learners


Do you have any questions?

Contact us

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