Free Live Webinar

How to Leverage AI in GxP Regulated Environments

Register Now
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Date

May 07 2025

Time
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)

Overview

In today’s highly regulated pharmaceutical and biotechnology industries, ensuring compliance while leveraging advanced technologies is a critical challenge. This webinar aims to bridge the gap between Artificial Intelligence (AI) innovation and GxP compliance.

Here, industry experts will explore how AI can be integrated into GxP-regulated environments to enhance operational efficiency, compliance, and quality assurance. The webinar will delve into practical applications and real-world examples, showcasing successful validation processes and business case results.

By attending this webinar, participants will learn:

1. How to approach AI-based implementation in GxP environments, including the associated validation processes.
2. Key takeaways from a detailed business case study, highlighting the tangible results and benefits of applying AI systems in regulated settings.
3. Best practices for integrating AI and Machine Learning technologies into pharmaceutical and life sciences processes, ensuring compliance with GxP guidelines.

Attendees will walk away with a deeper understanding of how to:

• Implement AI and Machine Learning in their GxP-regulated environments.
• Navigate the complexities of validating advanced technologies.
• Use case study insights to guide AI initiatives in their organizations, improving compliance, and streamlining operations.

The webinar will be presented by two seasoned experts in the field:

• Danilo Neri, Vice President Executive at PQE Group, brings over 20 years of experience in Computer System Validation and Serialization. As a globally recognized expert in Data Integrity Assurance and a PDA Certified Auditor, Danilo has led multi-site, international projects and contributed as a speaker at international seminars.

• Luca Zanotti Fragonara, Head of the Competence Centre in Advanced Technologies at PQE, specializes in AI and Machine Learning applications in structural, mechanical, and aerospace domains. With a Ph.D. in Structural Engineering and extensive experience leading European AI projects, Luca is at the forefront of validating AI systems for GxP environments and supporting strategic clients.

Don’t miss out on this opportunity to stay ahead in the GxP AI landscape. Register now and secure your place at this must-attend webinar.

Speakers

  • Danilo Neri
    Danilo Neri Vice President Executive & Board Equity Partner
    Danilo Neri
    Danilo Neri
    Vice President Executive & Board Equity Partner

    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.

  • Luca Zanotti Fragonara
    Luca Zanotti Fragonara Advanced Technologies Competence Center Lead
    Luca Zanotti Fragonara
    Luca Zanotti Fragonara
    Advanced Technologies Competence Center Lead

    Luca Zanotti Fragonara graduated in Structural Engineering from Politecnico di Torino in 2008 and earned his Ph.D. in 2012, specializing in modeling and nonlinear dynamics of complex systems. From 2014 to 2021, he conducted research at Cranfield University (UK), focusing on Applied Artificial Intelligence, including AI-driven diagnostics and computer vision in structural, mechanical, and aeronautical fields. He coordinated the European CompInnova project on robotic aircraft inspection, contributed to over 10 international projects like HumanDrive (AI validation for autonomous driving), published 50+ scientific articles, and supervised numerous theses.

    Luca founded and directed the MSc in Applied AI at Cranfield and collaborated with industry leaders such as Airbus and BAE Systems. Since 2021, he has led PQE’s Competence Centre in Advanced Technologies, supporting strategic customers, including Johnson & Johnson and Takeda, in AI and Machine Learning GxP-related initiatives. He is involved in European research projects such as COMFORT, further extending his expertise in cutting-edge AI applications. Luca continues to serve as a Visiting Academic at Cranfield University.

Partner

Pharma Quality Europe Srl
Pharma Quality Europe Srl
Website
https://www2.pqegroup.com/

With over 2,000 employees, PQE Group is a woman-owned leading Life Science consulting firm, providing full GxP Quality Support in every phase of the products' life cycle. With a focus on innovation, efficiency, and sustainability and with a global presence through its 45+ offices located around the world, PQE Group continues to set industry benchmarks and drive positive change in the Life Science sector.

  • Who Should Attend:

    Professionals in:
    Pharma, Biotech, MD companies, and CROs

    Positions:
    Quality Assurance Manager/Director
    Regulatory Affairs Specialist/Manager
    IT Manager/Director
    Validation Engineer
    Digital Transformation Lead
    AI/Data Scientist
    Pharmacovigilance Specialist
    R&D Scientist/Manager
    Clinical Operations Manager
  • Skill Level: Intermediate
  • Special event information:

    All participants will get a complimentary certificate of attendance courtesy of the webinar's partner - PQE.
Register Now

Date

May 07 2025

Time
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)

  • 00

    days

  • 00

    hours

  • 00

    minutes

  • 00

    seconds

Register Now

Speakers

  • Danilo Neri
    Danilo Neri Vice President Executive & Board Equity Partner
    Danilo Neri
    Danilo Neri
    Vice President Executive & Board Equity Partner

    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.

  • Luca Zanotti Fragonara
    Luca Zanotti Fragonara Advanced Technologies Competence Center Lead
    Luca Zanotti Fragonara
    Luca Zanotti Fragonara
    Advanced Technologies Competence Center Lead

    Luca Zanotti Fragonara graduated in Structural Engineering from Politecnico di Torino in 2008 and earned his Ph.D. in 2012, specializing in modeling and nonlinear dynamics of complex systems. From 2014 to 2021, he conducted research at Cranfield University (UK), focusing on Applied Artificial Intelligence, including AI-driven diagnostics and computer vision in structural, mechanical, and aeronautical fields. He coordinated the European CompInnova project on robotic aircraft inspection, contributed to over 10 international projects like HumanDrive (AI validation for autonomous driving), published 50+ scientific articles, and supervised numerous theses.

    Luca founded and directed the MSc in Applied AI at Cranfield and collaborated with industry leaders such as Airbus and BAE Systems. Since 2021, he has led PQE’s Competence Centre in Advanced Technologies, supporting strategic customers, including Johnson & Johnson and Takeda, in AI and Machine Learning GxP-related initiatives. He is involved in European research projects such as COMFORT, further extending his expertise in cutting-edge AI applications. Luca continues to serve as a Visiting Academic at Cranfield University.

Partner

Pharma Quality Europe Srl
Pharma Quality Europe Srl
Website
https://www2.pqegroup.com/

With over 2,000 employees, PQE Group is a woman-owned leading Life Science consulting firm, providing full GxP Quality Support in every phase of the products' life cycle. With a focus on innovation, efficiency, and sustainability and with a global presence through its 45+ offices located around the world, PQE Group continues to set industry benchmarks and drive positive change in the Life Science sector.

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