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In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”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
PQE Group
Executive VP - Principal Consultant
Danilo Neri is Vice President Executive and Board Equity Partner at PQE Group, bringing over 25 years of experience in pharmaceutical quality and compliance. He is an internationally recognized expert in Computer Compliance, Data Integrity, GMP/GDP compliance, and CSV/CSA, and has been a certified PDA Auditor since 2003. Danilo combines deep regulatory knowledge with practical digital transformation insight, helping organizations embed modern Quality 4.0 principles into real world operations, co-leading the relevant ISPE Interest Group.
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