One day course in GAMP 5 - with new updates

24 april 2026 09:00 - 17:00 @ Holländargatan 17, 111 60 Stockholm, Sweden

One day course in GAMP 5 - with new updates

One-day Course in GAMP 5

Welcome to an engaging and practice-oriented one-day course that gives you a clear and confident understanding of GAMP 5 Second Edition and how to apply the guidance in real-world projects. This course is designed for anyone working with computerized systems in regulated environments who wants to strengthen their knowledge, efficiency, and day-to-day decision-making.

Throughout the day, lectures are combined with discussions, reflections, and practical examples to help you see how GAMP principles come to life in practice.

What is GAMP?

GAMP (Good Automation Manufacturing Practice) from ISPE has long been one of the most influential guideline documents for computerized systems in regulated industries such as medical devices, pharmaceutical manufacturing, and research. It covers process control systems, laboratory operations, IT applications, infrastructure, and the entire computerized system lifecycle — including hardware, software, networks, operations, and supporting processes.

During the course, you will gain a solid overview of the latest version, GAMP 5 Second Edition, and how it is applied in practice. We will also explore the parallels between GAMP 5 and Computer Software Assurance for Production and Quality System Software, formally approved in September 2025.

Course Goals

After completing the course, you will be able to:

Understand the fundamentals and structure of GAMP 5
Recognize when and how the guidance is applicable
See how GAMP relates to regulatory requirements
Apply GAMP principles to develop computerized systems that are cost-effective, high-quality, and fit for their intended use

Prerequisites

No prior knowledge is required. Basic familiarity with GxP is beneficial but not necessary.

Agenda and Course Content

Fundamentals of GAMP 5, key concepts and practical application
Navigating the guide: structure, chapters, and when they are relevant
The system lifecycle approach — from concept to decommissioning — including requirements, design, and testing
The role of risk in GAMP, with focus on patient safety, data integrity, and product quality
Supporting processes throughout the system lifecycle
Practical examples and group discussions

When and where

Date: 24th of April 2026
Location: Westmanska palatset, Stockholm

Price

The price is SEK 9000 ex tax. Group discounts may be applicable. Please contact patric.helje@lemontree.se for more information.

Additional information

A two-course lunch, fruit and coffee are included.

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Björn will lead our GAMP 5 course, bringing extensive experience from industry projects within regulated environments, particularly in Life Science.

He has deep expertise in process and manufacturing systems, as well as in managing production and process data throughout the entire lifecycle in regulated industries.

With substantial experience in testing and validating computerized systems — especially complex data storage solutions — Björn has worked in roles such as Business Analyst, Validation Lead, and technical subject matter expert (SME).

As a course instructor, Björn stands out through his dedication, independent working style, and ability to energize the group. His results-oriented mindset, focus on quality, and passion for tackling challenges make him an inspiring guide through the principles and practical applications of GAMP 5.