Modernizing Quality Risk Management: Opportunities in Traditional, Digitalization, and AI Applications

Panelists:
Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Local Equity Partner, PQE Group
Rebecca Fuller, Vice President, Regulatory Compliance, QualityHub
Cindy Duhigg, Global Validation Steward, Alcon Laboratories

As quality and compliance expectations continue to evolve across the life science industry, organizations are being called to rethink and modernize their Quality Risk Management (QRM) frameworks. This webcast explores how companies can strengthen traditional approaches while integrating digital tools and AI-driven insights to make QRM more dynamic, predictive, and connected across functions. From updated regulatory expectations to real-world implementation strategies, our experts will examine how to effectively balance risk and innovation in today’s complex GxP environment.

Key Topics & Takeaways

• Explore foundational QRM principles and how they’re evolving in light of new technologies
• Review current regulatory guidance and expectations for modernized risk management approaches
• Examine how digitalization enhances QRM visibility, traceability, and responsiveness
• Learn how AI can support risk signal detection, prioritization, and real-time decision-making
• Understand challenges and lessons learned from implementing AI-enhanced QRM systems
• Explore risk-based approaches for computerized systems and data integrity
• Gain insights into cross-functional alignment and governance best practices
• Discover practical tools to assess, manage, and communicate risk in dynamic environments

Who Should Attend

Professionals working in:

• Quality Assurance & Quality Systems
• Risk Management & Compliance
• Regulatory Affairs
• Validation & CSV/CSA
• IT, Data Integrity & Digital Transformation
• Manufacturing & Operations