Webinar - Pharma 4.0: What does Quality 4.0 really require?
As part of the ISPE Pharma 4.0 Community of Practice Netherlands, this webinar series brings together leading ISPE experts to share practical insights on what is happening in Pharma 4.0 by connecting theory to real-world implementation.
Each session is designed to enable meaningful discussion: a focused 30-minute presentation is followed by a 25-minute interactive Q&A, creating space to explore challenges, perspectives, and practical implications with the audience.
In this session, the focus is on Quality 4.0, one of the key pillars in advancing digital, connected, and future-ready GxP organizations.
From Quality Islands to Connected Quality: what does Quality 4.0 really require?
In this session, Danilo Neri and Dr. Markus Zeitz present the upcoming ISPE guidance on Quality 4.0, offering a structured and practical perspective on how to build a future-ready, digitalized quality function.
They will explore the key drivers behind the guidance, its relation to Pharma 4.0, and the prerequisites for digitalized quality—from technology and data foundations to governance, people, and change management. The session will address how to move from fragmented “quality islands” to a connected systems landscape, enabling more efficient, inspection-ready QMS and integrated value and supply chains.
Expect insights into digitalized product lifecycle management, knowledge management, and the evolving definition of quality in a data-driven environment—along with a call to action through real-world use cases.
Register on webinar page / MS Teams:
Event Properties
| Event Date | 16-Apr-2026 12:00 - 12:00 |
| Capacity | Unlimited |
| Individual Price | Free |
| Location | Online - Teams |
Speakers
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.
Dr. Markus Zeitz
Head of Digital Quality
Dr. Markus Zeitz is Head of Digital Quality at Takeda, leading enterprise-wide digital transformation in GxP-regulated environments. With over 20 years of experience across Quality, IT, and R&D, he focuses on translating regulatory requirements into scalable, data-driven solutions. Previously, he held senior roles at Boehringer Ingelheim and Novartis, driving global quality digitalization, analytics, and emerging technologies. He is known for bridging Quality, Business, and IT to enable scalable GxP platforms and advance Quality 4.0.
