How to Leverage AI in GxP Regulated Environments

Course 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.