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Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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44th GAMP D-A-CH Forum | September 11, 2024
GAMP D-A-CH is a neutral platform for the exchange of information in the life science industry. The platform comprises suppliers and authorities in the German-speaking countries of Germany, Austria and Switzerland.
The aim of the platform is to strengthen the acceptance, awareness and application of the current GAMP guidelines. It also aims to contribute to the further development and success of the GAMP guidelines.
This year’s forum will take place on September 11 at the Böhringer Ingelheim Center. Oliver Herrmann, Head of GAMP D-A-CH, will guide the participants through the event and present the results of the local SIGs and WGs.
You can find further information on the 44th GAMP D-A-CH Forum here.
Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data
ISPE has just published the second edition of the GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and Data. QFINITY employees were part of the team that worked on this edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and data currently available.
The first edition was published in 2017. This update was necessary because the conduct of clinical trials has seen significant advances in recent years. The COVID-19 pandemic accelerated some of these changes, such as decentralized clinical trials. Industry changes have also prompted regulators to issue guidance such as the EMA’s “Guideline on computerized systems and electronic data in clinical trials” and the “Notice to sponsors on the validation and qualification of computerized systems for clinical trials”, both of which the update takes into account. The new edition also adds content on real world data / real world evidence, data protection in clinical trials, artificial intelligence and data science, and decentralized clinical trials. Last but not least, the guide has been aligned with GAMP 5 Second Edition.
You can find more information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data here.
View the Good Practice Guide at ISPE (ispe.org)↗
New QFINITY e-learning academy goes online
Starting this summer, the new QFINITY e-learning academy is going online! It offers e-learning courses on a range of topics related to GxP and the validation of computerized systems.
From free short courses that introduce the format to modular e-learning courses with a certificate – there is something for everyone, and we add new content continuously!
Current German-language courses:
Current English-language courses:
Why not take a look? Here is the link to the e-learning academy.
If you have further questions, feel free to contact us via our contact form.