GAMP 5 – Good Automated Manufacturing Practice
Good Automated Manufacturing Practice, GAMP 5 is the industry standard for life cycle management of computerised systems in the pharmaceutical, medical technology and LifeScience regulated industries. The guide covers requirements management, development, management and decommissioning of computerised systems. The guide also covers the support processes such as traceability, change management, document management etc, that are commonly needed in regulated industry. Legislation, guidelines, common concepts and terminology are reviewed and practical applications in the guide are presented and discussed. The training is interspersed with exercises and practical examples from real life.
Goal
After completing the course, the intention is that you will know the basics of how GAMP describes the life cycle of computerised systems. You should be comfortable finding, understanding and applying GAMP in practical applications.
Previous Knowledge
It is good to have basic knowledge in GxP and/or validation, verification or automation, but the course is adapted as needed. If desired, there is also a training part that practically goes through the basics of automation components and concepts to better understand GAMP
Agenda and Content:
- Legislation and guidelines found within LifeScience.
- GAMP5’s structure and “why GAMP”
- Terminology and basic concepts within the life cycle of computerised systems
- GAMP5s description of processes for:
- Requirements management
- Testing and verification
- Management
- Decommissioning of systems
- Risk management according to GAMP
- Support processes mentioned in GAMP 5
The training sessions mix normal briefings with exercises, own tasks and discussions.
Course Length
The course is normally completed in one day.
Contact patric.helje@lemontree.se for more information.
