Technical
In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”
Danilo Neri, PhD
PQE Group
Executive Vice President & Partner, CSV/CSA & Data Integrity Advisor
Graduated with a degree in Physics and a PhD in Engineering, Danilo Neri is a Principal Consultant with a demonstrated history of working in the pharmaceuticals industry and certified PDA Auditor in Computer Products Supplier Auditing Process Model since 2003.
Globally recognized as an expert in the fields of Data Integrity Assurance, Computer System Validation and Serialization, as well as PDA Certified Auditor and speaker at international seminars and events dedicated to Computer System Validation. 20+ years of experience in managing multi-site, international projects for MES, ERP and Serialization System Validation.
Member of PQE Group Board and Partner since 2004, he is now the Vice President Executive of the company.
Globally recognized as an expert in the fields of Data Integrity Assurance, Computer System Validation and Serialization, as well as PDA Certified Auditor and speaker at international seminars and events dedicated to Computer System Validation. 20+ years of experience in managing multi-site, international projects for MES, ERP and Serialization System Validation.
Member of PQE Group Board and Partner since 2004, he is now the Vice President Executive of the company.
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