ASTM E2500‑25 Unlocked: Smarter CQV for Legacy Facilities Virtual Event

Overview:

ASTM E2500-25 is the updated standard guide for the specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and builds on the established science-and risk-based philosophy of CQV while providing greater clarity, structure, and traceability across the asset lifecycle. Key additions, including Critical Design Elements (CDEs), a more formalized Design Qualification process, and graduated change control, help organizations focus effort where risk truly matters.

In this webinar, we will explore what these changes mean in practice, particularly for legacy facilities and existing validation programs. We will discuss how organizations can align with ASTM E2500-25 without unnecessary requalification, leverage existing commissioning and vendor documentation, and apply risk-based approaches to facility and equipment upgrades.

The session will also highlight how digitalization can support end-to-end traceability, reduce disruption during change initiatives, and transform CQV from a compliance activity into a valuable lifecycle asset.

• Understand the key additions in ASTM E2500-25, including Critical Design Elements (CDEs), Design Qualification, and graduated change control.
• Learn how to apply ASTM E2500-25 principles to legacy facilities and existing validation programs without unnecessary requalification.
• Discover how risk-based CQV can reduce downtime, duplicate testing, and disruption during facility and equipment upgrades.
• Explore how digitalization creates lifecycle value through traceability, reuse, and data-driven validation management.

Who Should Attend:

Ideal Market Sectors
Professionals working in regulated, innovation‑driven life‑science environments, including:

• Pharmaceuticals
• Medical Devices
• Biotechnology

Suitable Job Levels
This session is designed for decision‑makers, technical leaders and subject‑matter experts such as:

• Senior Directors
• Managers (M‑Level)
• Subject Matter Experts (SMEs)
• Team Leaders

Key Job Functions
Perfect for professionals responsible for compliance, quality and operational excellence across:

• Compliance
• Corporate Management
• Engineering
• Operations
• Production
• Quality
• R&D
• Regulatory Affairs

Relevant Job Titles
Those who will gain the most value include:

• Validation Professionals
• GxP Compliance Managers
• Engineering Managers
• CQV Managers
• Quality Assurance Managers
• Project Managers

Speaker: 

Francesco Minà is Vice President of Operations at PQE Group. He brings nearly three decades of experience in the life sciences industry, including more than twenty years at Johnson & Johnson, where he progressed from technical roles to senior leadership positions across Quality, Automation, Asset Management and Digital Operational Excellence.

His expertise encompasses Global Operations, Integrated Quality, CQV, Maintenance & Reliability, Digital Transformation, Industry X.0, AI-enabled manufacturing and organisational change within highly regulated environments. Francesco is passionate about translating emerging technologies into scalable, data-driven operating models that generate measurable business value while keeping people at the centre of transformation.

He is also an active startup investor and advisor, supporting innovation, continuous learning and the development of resilient, future-ready organisations. 

Moderator 

John Wrenn is currently a serving Board member of the ISPE Australasia Affiliate and brings extensive technical commissioning, qualification, validation, project management and client management experience. With over 20 years of professional engineering experience, he has a background in Mechatronics and has years of hands-on technical experience encompassing areas such as calibration, biomedical engineering, medical packaging design & validation, medical devices, and pharmaceuticals and has performed project work for multinational companies such as CSL Behring, Cochlear, Aroa, Poly Novo, Vaxxas, Boston Scientific, Genea Biomedx, J&J Vision, Jazz Pharmaceuticals, MSD and Moderna. He is currently the General Manager for PQE Group Australia.

Webinar Access and Privacy Information:

The webinar will be hosted on the Zoom platform provided by PQE Group. Any information shared with PQE Group during registration will be used solely for webinar-related purposes.