Systems GxP, data integrity, quality, validation
Big success for 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 dedicated to the Theme:
PHARMA 4.0: impacts and new approaches for GxP compliance of computerized systems
What exactly is Pharma 4.0? What does it include?
What are the current impacts and changes on approaches to mastering computer systems: regulations, guidance, methodologies and technologies?
How do regulatory agencies like the FDA adapt their approaches to this new paradigm?
What changes are coming to organizations to adapt to Pharma 4.0?
Pharma 4.0 is the dominant theme in the digitalization of the pharmaceutical industry and the approach to intelligent manufacturing with a very high level of automation is bringing about significant changes.
Regulatory authorities are putting increasing pressure on the application of current requirements for risk management, data integrity and safe management of the entire life cycle of pharmaceutical products.
The expansion of pharmaceutical quality systems with widespread digitization requires new approaches and new organizations.
The possibilities of new blockchain digital technologies will also certainly be used to help meet the challenges and opportunities of this Pharma 4.0.
During this Workshop, we invite you to decode Pharma 4.0, its impacts, the new tools, as well as the new approaches being developed by the FDA. We will present concrete cases on the adaptation of IT Quality approaches to Pharma 4.0.
Thank you to all our customers for the quality of the exchanges (bioMérieux, FAMAR, SANOFI PASTEUR, GETINGE Intervascular, LABORATOIRE ARROW, NOVASEP, Maat Pharma, Fresenius Vial SAS).
As part of our development, we are strengthening our teams.