Webinar - Pharma 4.0: Quality 4.0

Danilo Neri

Partner & Vice President Executive at PQE Group

Danilo Neri is a Principal Consultant with more than 25 years of experience in the pharmaceutical and life sciences industry. He is currently Vice President Executive and Board Equity Partner at PQE Group, a leading global quality service provider for life sciences, where he has been active since 1998. Daniolo is a certified PDA Auditor in the Computer Products Supplier Auditing Process Model (since 2003) and is internationally recognised for his expertise in Quality 4.0–related domains. His core competencies include Data Integrity Assurance, FDA/EMA/ANVISA/PMDA inspection support, EU and US GMP/GDP compliance, and Computer Software Assurance and Validation (CSV/CSA). He also brings deep knowledge of software life cycle standards (IEC 62304), Agile practices for medical device software development (AAMI TIR45), Quality Management Systems (21 CFR Part 820, ISO 13485), and Risk Management (ISO 14971). Throughout his career, Daniolo has held multiple senior leadership roles within PQE Group, combining strategic responsibility with hands-on consultancy. In his Pharma 4.0 webinar session, he will share a pragmatic and experience-driven perspective on how Quality 4.0 principles can be effectively embedded into modern pharmaceutical and medical device organizations.