Optimize the quality and time spent in the development of your computerized systems using Good Automated Manufacturing Practice (GAMP). The course is designed to provide you with targeted knowledge of GAMP5 methods and their practical application, enabling you to ensure product quality, data integrity, and patient safety.
Automation and IT engineers.
Project engineers and managers.
QA employees and managers.
IT responsible.
Process technicians and chemists.
Machine builders and robot suppliers.
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Havnevej 1, 1 tv. 4000 Roskilde 
Dansk / Engelsk
The teaching material will be in English.
Teaching is in English.
Good Automated Manufacturing Practice (GAMP) provides a logical and systematic approach to the categorization, documentation, and risk assessment of automated systems. In this course, you will gain targeted knowledge of how GAMP 5 methods can help you ensure that patient safety, product quality, and data integrity are properly maintained in your computerized systems.
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.
Computer System Validation (CSV) is becoming an increasingly important part of the pharmaceutical industry as a larger share of production is controlled digitally.
Both instruction and course material will be in English on our English courses.
The course will consist of a mix between theoretical overview of the GAMP 5 guide and what it means in practice. We will use a ”practical project” as reference and use it for relevant examples and exercises.
To be able to make our course even better we will ask all participants to evaluate the course on the last day.
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