Consulting

// Description

Validant

May 2019 – August 2019, Senior Life Science Consultant assigned to an AIFA Inspection readiness project;
April 2019 – May 2019, Senior Life Science Consultant assigned to a Clinical Trial Center Qualification Audit;
January 2019 – March 2019, Senior Life Science Consultant assigned to an FDA Inspection readiness project

// In detail

In charge of supporting a mitigation project, following the negative repercussions of an AIFA inspection event in the TAPI (Teva API) Italy plant;
In charge of supporting a certification project of a white blood cell collection area (CAR-T) for plasmapheresis, in the hospital of Padua, necessary for the execution of personalized Immuno-Oncology clinical trials on cancer patients, on behalf of a Biotek , Start-up, Californian;
In charge of supporting an FDA inspection preparation project for maintaining certification status for export to the US market, in a TEVA Italy plant

STRATEGIC CONSULTANCY

Specialist consultancy