Danilo Neri

Vice President Operations - Partner, PQE Group

Degree in Physics at the University "La Sapienza" of Rome, PhD in Electronic Engineering at the University “Roma Tre”, Rome. He has been working as Senior Validation Consultant for Motherwell Information Systems, Milan. Since 1999 he has been working for PQE as Validation Project Manager with expertise on Computer System Validation and compliance to 21 CFR Part 11 and EU GMP Annex 11. In 2003, he got the PDA certificate as Auditor of Computer Products Suppliers.
In over 10 years of experience, he has managed the validation process for the Computerised System used in the Life Science environment (e.g. ERP, MES, LIMS, EDMS, eCRF) and he has support the implementation of Quality Systems for the IT governance. He has executed many audit to Computer Products Suppliers and it has presented a number of lectures in international congresses.