Governance, Risk, and Readiness: Building the Future of Pharmaceutical Quality at the 2026 ISPE Annual Meeting & Expo

Bringing together industry leaders, regulators, quality professionals, and technology innovators, this track will explore the frameworks, strategies, and real-world applications needed to ensure organizations are prepared for the future. From AI governance and quality management maturity to risk-based decision-making and supply resiliency, attendees will gain actionable insights that can be applied immediately within regulated environments.

Advancing Responsible AI in cGMP Operations

Artificial intelligence is no longer a future concept in pharmaceutical manufacturing: it is already transforming how companies manage quality, documentation, and operational efficiency. The session “Implement and Manage Risks for AI Solutions in cGMP” will showcase how AI-driven technologies are being successfully deployed across pharmaceutical manufacturing environments.

Presented by Loganathan Kumarasamy, Head of Regulatory Compliance Solutions at Zifo Technologies, and Arif Azad, PhD, Director of Engineering Validation at Pfizer, the discussion will examine practical applications including AI-enabled periodic reviews, automated GxP documentation generation, and intelligent batch record review systems.

While these use cases demonstrate significant benefits, the session also addresses the risks that accompany AI adoption. Topics such as data integrity, algorithmic bias, model transparency, and ethical considerations will be explored through the lens of evolving regulatory expectations. Attendees will leave with a deeper understanding of how to identify, assess, and mitigate AI-related risks while maintaining compliance and product quality.

Preparing Quality Systems for AI Adoption

As AI becomes embedded within GMP operations, organizations must ensure their quality systems are ready to support it. In “The AI-Ready Quality Management System (QMS): A Playbook for GMP Manufacturers,” Daniel Thorne Ringgaard, Senior Consultant at Kuatro Group, presents a structured approach to preparing quality management systems for both autonomous AI and human-in-the-loop decision-support tools.

This session will walk participants through the practical elements of AI readiness, including policy updates, standard operating procedure revisions, model specification templates, and risk assessments. A particular focus will be placed on AI validation procedures and how these frameworks were successfully implemented at a pharmaceutical manufacturer.

For organizations wondering how to bridge the gap between traditional quality practices and emerging AI governance requirements, this presentation offers a clear and replicable roadmap.

Managing Generative AI in GxP Environments

Few emerging technologies have generated as much excitement—and concern—as generative AI. During “Controls for Retrieval-Augmented GenAI in GxP,” Ulrich Koellisch, PhD, Partner at GXP-CC GmbH, and Pradeep Ravindra, Senior AI Product Manager at Koerber Pharma Software, will explore how organizations can deploy GenAI responsibly in regulated environments.

The session introduces a validation and data governance framework designed specifically for retrieval-augmented generation architectures. Attendees will gain insight into model governance, data management, cybersecurity safeguards, automated data flow controls, and access management within AI-driven systems.

Using a practical pharmaceutical use case, the presenters will demonstrate how AI-enabled information services can support manufacturing operations while maintaining audit readiness, regulatory compliance, and adherence to ALCOA+(+) data integrity principles.

Elevating Quality Maturity Across the Enterprise

Strong governance begins with a mature quality culture. The “Quality Advantage: Advance Your Quality System Maturity” session will examine ISPE’s Advancing Pharmaceutical Quality™ (APQ) Program and its structured framework for improving pharmaceutical quality systems.

Industry experts Michael Grischeau of AbbVie and Tami Frederick of PAI Pharma will discuss how organizations can assess current quality maturity levels, identify improvement opportunities, and implement meaningful change. Attendees will also hear lessons learned from APQ case studies and insights from the US Food and Drug Administration (US FDA) Quality Management Maturity (QMM) pilot programs.

For leaders focused on building resilient, continuously improving quality organizations, this session offers valuable benchmarks and practical guidance.

A New Perspective on Risk Management

Risk management has traditionally been viewed as a compliance exercise. The Governance, Risk, and Readiness track challenges that mindset through sessions focused on making risk management a strategic business capability.

In “Introduction of Risk Management Maturity Model,” Fubin Wu, Co-founder and President of GessNet, introduces a framework designed to help organizations embed risk management throughout the product lifecycle. The model evaluates key dimensions such as leadership, culture, lifecycle integration, cross-functional collaboration, traceability, and organizational learning.

Attendees will learn how to identify maturity gaps and establish a proactive, patient-focused approach that strengthens both product quality and business decision-making.

Understanding US FDA Quality Management Maturity

US FDA’s growing emphasis on Quality Management Maturity continues to influence industry strategies around quality and operational excellence. In “FDA QMM: Proactive Transformation for Pharma Sites,” William Hauck and Sarah Akers of Shabas Solutions LLC will examine how QMM frameworks move organizations beyond reactive compliance toward sustainable excellence.

The presentation will explore the US FDA’s five QMM practice areas, including Advanced Pharmaceutical Quality Systems, Business Continuity, Management Commitment to Quality, Employee Engagement and Empowerment, and Technical Excellence. Real-world examples will illustrate how organizations can enhance resilience, improve supply reliability, and strengthen quality culture across operations.

Building Governance for the Digital Era

Digital transformation creates new opportunities for collaboration, but it also raises complex governance challenges. In “Govern Cloud Collaboration: A Pharma–Regulator Blueprint,” Jean-Pierre Doan of Merck KGaA addresses one of the industry's most pressing questions: how pharmaceutical companies and regulators can collaborate effectively within cloud-based environments.

Drawing on a case-study scenario, this presentation explores governance frameworks addressing legal structures, data ownership, liability, transparency, decision-making, and compliance verification. The session provides a practical roadmap for moving cloud collaboration from experimental pilots to trusted industry practice.

Creating an Inspection-Ready AI Playbook

Organizations implementing AI in GxP environments often struggle to create comprehensive documentation that will withstand regulatory scrutiny. The interactive workshop “What’s in Your AI Playbook?” tackles this challenge directly.

Led by Gaurav Walia of PQE Group, John Clapham of PSC Biotech Corporation, and Rose Mary Aversa of ProQuality Network, participants will work through essential components of an inspection-ready AI governance narrative, including intended use, data classification, data flow, documentation structure, lifecycle management, release controls, monitoring, and access management.

This highly practical workshop promises valuable takeaways for quality, compliance, validation, and digital governance professionals.

Strengthening Supply Resiliency Through Governance

The Governance, Risk, and Readiness track also highlights the growing connection between quality culture, governance, and drug shortage prevention. Sessions covering the ISPE Drug Shortages Initiative, cultural excellence, US FDA perspectives on shortage prevention, and quality management systems for emerging therapies demonstrate how governance extends beyond compliance to support reliable patient access and resilient supply chains.

Attendees will learn about tools such as the 2023 ISPE Drug Shortages Prevention Model and the Drug Shortages Assessment and Prevention Tool, both designed to help manufacturers strengthen proactive shortage prevention programs. Additional discussions will explore the role of cultural excellence in sustaining quality-focused organizations and supporting long-term supply reliability.

Expanding Risk-Based Thinking Across Emerging Challenges

The track also extends governance and risk management discussions into specialized manufacturing environments. Sessions such as “Are Leaks Always a Failure? Science vs Perception” will challenge traditional assumptions regarding leak events in pharmaceutical manufacturing by exploring science-based, risk-informed decision-making approaches.

Meanwhile, “Quality Management System Anticipates Cell and Gene Therapy Challenges” will examine how phase-appropriate and risk-based quality assurance strategies can help organizations navigate the unique complexities of autologous cell and gene therapy manufacturing. These discussions reinforce the importance of applying governance and readiness principles across every stage of the product lifecycle.

Join the Conversation Shaping the Industry's Future

The Governance, Risk, and Readiness track at the 2026 ISPE Annual Meeting & Expo offers a unique opportunity to learn from the organizations leading the industry’s transformation. Whether your focus is AI governance, quality management maturity, risk management, regulatory collaboration, supply resiliency, or digital readiness, these sessions provide practical strategies for building compliant, future-ready operations.

As the pharmaceutical landscape continues to evolve, governance and risk management have become strategic differentiators. The insights shared will help organizations not only meet regulatory expectations but also drive innovation with confidence.

Learn more and register today.