Big success for the Pharmasys Workshops in November

Pharmasys regularly organizes customer workshops in Paris, Lyon and Lausanne. In 2019, in Lausanne on November 19, in Lyon on November 20, and in Paris on November 21, the Workshops are devoted to the Theme: PHARMA 4.0: impacts and new approaches for GxP compliance of computerized systems.

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What is Pharma 4.0 exactly? What does that include? What are the impacts and ongoing changes on approaches to controlling computerized systems: regulations, guidelines, methodologies and technologies?
How are regulatory agencies like the FDA adapting their approaches to this new paradigm? What are the upcoming changes in organizations to adapt to Pharma 4.0? Pharma 4.0 is the dominant theme in the digitalization of the pharmaceutical industry and the intelligent manufacturing approach with a very high level of automation is causing significant changes.

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Regulatory authorities are putting increasing pressure on the application of current requirements for risk management, data integrity and the safe management of the entire life cycle of pharmaceutical products. The extension of pharmaceutical quality systems with widespread digitalization requires new approaches and new organizations. The possibilities of new digital technologies such as Blockchain will certainly also be used to help meet the challenges and opportunities of Pharma 4.0. During this Workshop, we invite you to decode Pharma 4.0, its impacts, new tools, as well as new approaches being developed by the FDA. We will present concrete cases on the adaptation of IT Quality approaches to Pharma 4.0. Thanks to all our customers for the quality of the exchanges (bioMérieux, FAMAR, FAMAR, SANOFI PASTEUR, GETINGE Intervascular, LABORATOIRE ARROW, NOVASEP, Maat Pharma, Maat Pharma, Fresenius Vial SAS).

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