May 14th - 09:00-17:00 - ONLINE
About GAMP
GAMP (Good Automation Manufacturing Practice) from ISPE, since its release, has probably been the most influential guideline document for computerized systems in regulatory industries such as medical device, pharmaceutical production and research and covers both process control systems, laboratory operations, IT applications and infrastructure. The document covers the entire computerized system, which includes, for example, computers, networks, IT infrastructure, operation and management, hardware and software, and support processes for computerized systems. In this course you get a good overview of the latest version of GAMP, i.e. GAMP 5 second edition, and how you apply GAMP 5 in practice.
Goal
After completing the course, you should know the basics of the GAMP5 guide, how to find it and when it is applicable. You will gain an understanding of how the guide relates to the regulations and how it can be used to create computerized systems that are cost-effective, high-quality and adapted to their intended use.
Previous knowledge
No prior knowledge is required, but a basic knowledge of GxP is an advantage.
Agenda and content
- The basics of GAMP 5, fundamental concepts and how they are used.
- Navigation in the guide, which parts are included and when these are useful.
- The life cycle approach for a system, from idea to decommissioning, including requirements management, design and testing.
- The concept of risk in GAMP, with a focus on achieving patient safety, data integrity and product quality.
- Support processes used during a system's life cycle.
We also go through how to apply GAMP in practice.
The training sessions are based on lectures that are mixed with discussion points.
When? May 14th 2025
Where? Online - link will be sent out the days before
Price: 6 000 SEK ex moms
Group discounts may be applicable, please contact Tom Abbu at
tom.abbu@lemontree.se
Please note that this course will be held in English.
However, in November, we will offer an in-person GAMP 5 course in Stockholm, conducted entirely in Swedish. Please go to our event page to learn when. 
