Computerized systems are an essential part of the pharmaceutical and medical device industry, from research and development to clinical trials, manufacturing and distribution. Computerized systems used in the GxP environment must be reliable and adapted to their needs. This course provides an understanding of regulatory requirements and how to effectively quality assure computerized systems.
Who should attend?
The course is aimed at those who work with computerized systems and need an overview of what Good Automated Manufacturing Practice (GAMP) means, focusing on the point of view of IT managers, system and process owners, system suppliers, project managers, automation engineers, validation managers and quality assurers.
Course content and structure
The training day consists of lectures, discussions and group work in the following areas:
- What is validation and what do the rules say?
- Why is validation carried out?
- What regulations and guidelines exist?
- FDA 21 CFR Part 11
- Eudralex Volume 4 Annex 11
- Introduction to GAMP 5
- Why GAMP? History, background and regulatory framework
- Key concepts
- Life cycle model, projects, management and decommissioning
- Effective validation
- Categorization of systems
- Scalability
- Critical functions and risks
- Management of systems
- What should be in place?
- The role of the supplier
- What is the supplier's responsibility
- Supplier cooperation
Time and place
The course is held in person at Apotekarsocieteten, Wallingatan 26A in Stockholm.
