Synthon Hispania has hold in their premises a new meeting of Foro ManageArt, and the members had a new opportunity to discuss about hot topics in the Pharma Industry: “Continuous Process Verification” (CPV) and “Data Integrity” (DI) projects. With more than 50 participants in a very positive environment it was discussed about what, when, how and who of each project activity have been done in every company.
Continuous Process Verification
Synthon made a presentation about their experience regarding CPV project, as Synthon has huge experience as they had to start early due to a big client request.
Although it was a must due to a new regulation, CPV could be assumed as an opportunity to work better and to have the opportunity to guaranty the process robustness for all the products manufactured.
They discuss about the project approach, the methodology, consultant partners and how to avoid main and common problems in developing CPV. It was of course very useful for those companies that are starting with the project.
The second part of the session was leaded by Esteve, who presented the evolution of their internal project of Data Integrity, which involved 7 sites around the world and more than 400 systems.
After the phase of Gap identification, they made an action plan related to organization, procedures and technological issue. Final activity was to organize audits and inspections.
For such an intensive project, training and sensitization were two main issues absolutely demanding although there were some other requirements, like team organization, new skills required, partners identification, etc.
It was a successful workshop where the different members of the Foro could share different visions and make network in order find help while implementing both projects inside their companies.