La correct management of electronic data (“DATA INTEGRITY”) it's a topic came back violently actuality in the light of the latest regulatory updates and numerous non-conformities found from the principals Regulatory Bodies, such as that European (EMA) e US (FDA)I Non-Compliance Report (EMA) and the Warning Letters (FDA) show that the problem is not confined to laboratory areas and some geographical areas but is rather widespread in much of the industrialized world.
Starting from an analysis of recent guidelines (issued by the MHRA and WHO) and from their comparison with those now known (US FDA 21 CFR Part 11, EU GMP Annex 11), practical examples of how to implement systems of automation they can ensure “data quality and integrity” through the Validation process.
This approach ensures documented evidence that the electronic data generated by the automation system can retain those required integrity attributes today da most of the regulatory bodies throughout its life cycle.
This is just one example: other topics were addressed during the free Workshop at the AFI Symposium in Rimini.
WORKSHOP AGENDA AND PROTAGONISTS (complete agenda)
DOWNLOADABLE PRESENTATIONS (all presentations available soon)
INTERVENTION 2: “Efficiency and effectiveness in Life Science productions” – Key Note Speaker: Prof. Claudio Rolandi – SUPSI – Department of Innovative Technologies – Advanced Studies
Prof. Claudio Rolandi – SUPSI, Polytechnic of Lugano INTERVENTION 2: "Compliance for Data Integrity in automation systems according to GAMP - standards and examples" – Andrea Franco – Pharma Quality Europe srl
Andrea Franco – PQE Rome INTERVENTION 3: “Fully integrated SCADA platform on a complex filling line under isolation technology for liquid & lyophilized products” – Davide Frabboni – Product Manager IMA SpA – IMA Life division – Sales & Marketing department
Presentation of IMA Life INTERVENTION 4: "Automation systems with modular and distributed architecture: correct design to support Data Integrity" – Ing.Alessandro Ferroni – Director of Engineering Dompé farmaceutici SpA
Ing. Alessandro Ferroni – Engineering Manager DOMPE' FARMACEUTICI INTERVENTION 5: “Innovative tools for data collection, big data and analytics from an Industry 4.0, Industrial Internet and Cloud perspective” – Michael Desloges – GE Digital Marketing Mgr
Mikael Desolges – Head of Marketing Europe GE Digital
THEME OF THE SYMPOSIUM: "Evolution of the pharmaceutical sector: radical changes in the drug supply chain"
How are the issues of Efficiency, Quality and Compliance addressed today? What will change tomorrow?
How are Raw Data managed, thus guaranteeing Data Integrity even in the FDA inspection phase?
If these issues are important to you, don't miss the meeting on Wednesday 8 June in Rimini, a Workshop with free registration to remove any doubts and get to know who deals with these issues (proposing effective solutions) on a daily basis.
DOWNLOAD OUR FREE WHITE PAPER ON THE TOPIC OF DATA INTEGRITY
AGENDA AND PROTAGONISTS OF THE WORKSHOP
PDF04_Ferroni Dompe Workshop DataIntegrity_simplif
03_IMA LIFE – GE – iFIX SCADA presentation for AFI Symposium