The training combines theory with practical exercises and discussions based on the students' own experiences and challenges. We value learner feedback to ensure continuous improvement of our courses.
Get a hands-on approach to ensuring data integrity in your GxP systems, with a focus on practical solutions to maintain compliance. Data integrity in GxP systems has become increasingly important in light of the increased focus of authorities and inspectors in recent years. Our course is based on ISPE's guide "Records and Data Integrity" and GAMP 5, and provides a comprehensive review of how to implement and maintain data integrity in practice.
Data owners
Process owners
Project managers
Project engineers
QA employees
Machine suppliers
Robot suppliers
IT suppliers
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Havnevej 1, 1 tv, 4000 Roskilde 
Danish / English
The teaching material will be in English.
Teaching will be in Danish.
Data integrity in GxP systems has received increasing attention from regulators and inspectors in recent years.
In 2017, ISPE released the Records and Data Integrity guide to help interpret regulatory expectations with industry options for keeping GxP data in compliance. The guide is aligned with ISPE's GAMP 5 guide and has the distinction of taking all other essential data integrity guides into consideration and encompassing them in one comprehensive guide.
The course gives you a thorough introduction to the guide with a strong emphasis on a practical approach (production, laboratories, IT systems, etc.). There will be ample opportunity to work with issues and systems from your own everyday life, and there will be cases and exercises based on concrete issues from the real world.
The training combines theory with practical exercises and discussions based on the students' own experiences and challenges. We value learner feedback to ensure continuous improvement of our courses.
On the course you will achieve:
