How Pharma 4.0™ Supports Inspection-Ready Compliance at the 2026 ISPE Pharma 4.0™ and Biopharma Conference

These critical topics are the focus of the Pharma 4.0™ Compliant by Design track at the 2026 ISPE Pharma 4.0™ and Biopharma Conference, taking place 10-11 December in Berlin, Germany, and virtually.

As a leading interdisciplinary event for pharmaceutical professionals, the conference will explore the latest innovations, trends, and practical solutions across manufacturing, quality, supply chain, facilities, and regulatory operations. The Pharma 4.0™ Compliant by Design track specifically examines how organizations can create digitally enabled, data-driven, and inspection-ready systems that support both operational excellence and regulatory compliance.

Through real-world case studies and expert perspectives, attendees will learn how to strengthen contamination control strategies, improve cybersecurity resilience, implement Quality 4.0 frameworks, govern cloud-based data ecosystems, advance continued process verification (CPV), scale digital manufacturing architectures, and apply AI responsibly within GxP environments. From digital twins and connected quality systems to human oversight of AI and compliance considerations for advanced therapy medicinal products (ATMPs), the track provides practical guidance for organizations seeking to accelerate digital transformation while maintaining regulatory confidence and inspection readiness.

What Does "Compliant by Design" Mean in Pharma 4.0™?

Pharma 4.0™ promotes the integration of people, processes, technology, and data across the pharmaceutical product lifecycle. As organizations adopt advanced analytics, AI, connected manufacturing systems, and cloud platforms, compliance must evolve alongside innovation.

A compliant-by-design approach focuses on:

• Trusted and governed data ecosystems
• Digital quality management systems
• Real-time process monitoring
• Secure and resilient cyber-physical infrastructure
• AI governance and human oversight
• Inspection-ready electronic records and evidence
• Lifecycle quality risk management
• Data integrity across interconnected systems
• Risk-based lifecycle assurance and controlled change
• Defined human accountability and oversight
• Inspection ready electronic records and supporting evidence

Compliant by design does not mean that technology is inherently compliant. It means that applicable requirements, intended use, risks, controls, data governance, and evidence needs are considered throughout design, implementation, operation, and change. The sessions within this track demonstrate how leading pharmaceutical companies and technology providers are putting these principles into practice.

Moving from Reactive to Predictive Contamination Control

The track begins with "Contamination Control in Pharma with Digital Twins," presented by Davide Fissi, PhD, Senior Principal, Engineer Utilities, at Eli Lilly Italia SpA.

As regulatory expectations increasingly emphasize proactive, risk-based contamination control, organizations are seeking new ways to strengthen their contamination control strategies (CCS). Fissi will demonstrate how appropriately qualified and validated digital-twin applications can support a transition from reactive monitoring toward more predictive contamination control approaches.

The session explores how technologies can improve contamination control, optimize maintenance strategies, and support more proactive contamination prevention and improved control of cleanroom operations. These include:

• 3D capture and building information modeling
• Computational fluid dynamics
• Internet of Things-enabled environmental monitoring
• Machine learning-based anomaly detection
• Virtual risk assessments

For organizations working to align with EU GMP Annex 1 requirements, this presentation offers practical insight into the future of contamination prevention.

Understanding Cybersecurity in Connected Pharma Operations

As operational technology and manufacturing systems become increasingly interconnected, cybersecurity has become a critical component of quality and compliance.

In "Pharma 4.0™ Cyber-Resiliency," Wolfgang Winter, Strategic Program Lead, Enterprise Software and Customer Success at Agilent Technologies Deutschland GmbH, joins Nick Robbins, Automation Director at GSK, and Rob Innes, Director of Data Analytics at Digital Technologies Group (DTG).

Together, they will examine cybersecurity risks associated with Pharma 4.0™ cyber-physical systems and discuss best practices for reducing vulnerabilities, improving detection capabilities, and maintaining resilient smart factory environments.

The session also addresses evolving regulatory requirements, including emerging cybersecurity legislation and industry expectations. Attendees will gain valuable perspectives on developing integrated security strategies that align with existing quality, safety, validation, and risk management frameworks.

Creating a Connected Quality 4.0 Ecosystem

Quality operations remain at the center of any compliant digital enterprise.

In "Proactive, Data-driven, Connected Quality 4.0," Markus Zeitz, PhD, Quality Manager at Takeda, and Danilo Neri, Executive Vice President and Principal Consultant at PQE Group, will outline practical implementation strategies for Quality 4.0 programs.

Based on more than 20 real-world use cases, the presentation explores how organizations can transition from paper-based compliance models to connected quality ecosystems that link manufacturing, laboratories, suppliers, logistics, and quality functions.

The session highlights several important concepts, including:

• Process management as the foundation for digitalization
• Data-centric quality architectures
• End-to-end value chain integration
• AI-enabled quality decision-making
• Knowledge management and quality risk management as key enablers

Organizations seeking a roadmap for implementing Quality 4.0 initiatives will find actionable guidance throughout this session.

Addressing One of Pharma's Biggest Governance Challenges

Data sharing between industry and regulators is becoming increasingly important, yet governance models often lag behind technological capabilities.

Jean-Pierre Doan, Associate Director Innovation, Regulatory, Research and Development Quality, Patient Safety at Merck KGaA, addresses this challenge in "Demystify Cloud Data Governance: Industry Meets Agency."

Using a real-world case study, the presentation examines how pharmaceutical organizations and regulatory authorities can securely collaborate in cloud environments while maintaining governance, traceability, and trust.

Topics include:

• Cross-organizational data ownership
• Access control and sovereignty
• Cryptographic trust frameworks
• Governance of agentic AI workflows
• Regulatory implications of cloud collaboration

The session offers a forward-looking perspective on how future regulatory collaboration models may evolve.

Leveraging Data for Continuous Verification and Reliability

Data-driven quality requires more than visibility; it requires actionable insights.

In "Data Centric Approach to CPV and Equipment Reliability," Paolo Braiuca, PhD, Industry Principal, Pharma at Seeq Corporation, explores how advanced analytics can support continued process verification and equipment reliability initiatives.

Attendees will learn how integrated analytics ecosystems can enable:

• Statistical process control
• Condition-based monitoring
• Advanced batch reporting
• Real-time quality insights
• Improved equipment performance

The presentation demonstrates how companies can move beyond passive monitoring toward integrated quality and operational excellence.

Scaling Digital Manufacturing Across Global Networks

A recurring challenge in Pharma 4.0™ is scaling successful initiatives across multiple facilities.

In "Scaling UNS Data Foundation for MDC, OPV, OEE and MES/EU," Igor Tomasevic, Global Automation Leader at STADA, Jelena Batinic, Scale-up Manager, Manufacturing Science and Technology at STADA, and Andre Boyce, Automation Department Manager and Consultant at Arcadis, share practical lessons from expanding a Unified Namespace (UNS) architecture across global manufacturing operations.

The session demonstrates how a modern data foundation can improve:

• Data integrity
• Ongoing process verification
• Overall equipment effectiveness
• Manufacturing visibility
• Resource optimization

This presentation highlights the importance of scalable infrastructure in supporting enterprise-wide Pharma 4.0™ initiatives.

Exploring the Next Frontier of AI in Quality Operations

AI features prominently throughout Day Two (11 December) of the Compliant By Design track.

In "AI-Driven QMS Simplification in Pharma," Abhinav Arora, Director at ReveonAI Lifesciences Private Limited, and Devendra Sharma, Director at ReveonAI Lifesciences Solutions Private Limited, demonstrate how AI agents can assess, rationalize, and simplify quality documentation while maintaining GMP compliance.

The discussion continues with "Agentic Deviation Investigation," where Lukas Weber, Associate Director Manufacturing Modernization at Teva Pharmaceuticals, explores AI-assisted workflows that support faster, more consistent deviation investigations through knowledge retrieval, contextual analysis, and hypothesis generation.

Together, these sessions provide practical examples of how AI can reduce administrative burden while strengthening quality decision-making.

Preparing for the Future of Digital Inspections

As regulatory agencies become increasingly data-driven, inspection readiness remains a top priority.

Several sessions directly address this evolving landscape.

In "Electronic Logs: Intelligent Operations for Pharma 4.0™," Pavan Pasupulati, Vice President – Manufacturing Portfolio at Caliber Technologies, examines how AI-powered electronic logs and workflow orchestration can improve compliance, consistency, and operational intelligence.

Yanet Flor, GMDP Quality Auditor and Quality Manager at GMP Check, takes a compliance-focused approach in "What Inspectors Really Expect from Pharma 4.0™ Systems – Powered by ISPE Women in Pharma^®." Drawing on practical GMP inspection experience, Flor will discuss regulatory expectations for data integrity, governance, audit trails, user access management, AI-supported processes, and digital evidence.

These insights are particularly valuable for organizations seeking to strengthen inspection readiness in increasingly digital environments.

Building Human Oversight into AI-Enabled GxP Systems

While AI creates significant opportunities, quality oversight remains essential.

In "Human Oversight by Design: Progressive QA for AI-Enabled GxP Systems," Oliver Herrmann, Managing Director at QFINITY Quality Management, explores how quality assurance functions must evolve to support AI-enabled regulated systems.

Drawing from insights shared in the ISPE GAMP^® Guide: Artificial Intelligence, this session introduces the concept of progressive quality assurance and demonstrates how effective oversight can be embedded into system architecture from the outset, ensuring reliability, transparency, and scalability.

Understanding Compliance Requirements for ATMP Digitalization

The track concludes with "ATMP Digitalization: Compliance in Practice," presented by Sharon Adderley, PhD, European Director of Regulatory Compliance at Arcadis.

As advanced therapy medicinal products continue to reshape the pharmaceutical landscape, organizations face unique regulatory and operational challenges.

The presentation examines current regulatory expectations in the European Union and United States for digital manufacturing, data integrity, computer software assurance, process analytical technology, advanced control strategies, and real-time monitoring apply within ATMP environments. Attendees will gain practical guidance for navigating rapidly evolving regulatory frameworks while supporting innovation.

Why the Pharma 4.0™ Compliant by Design Track Matters

The Pharma 4.0™ Compliant by Design track provides a comprehensive look at how pharmaceutical organizations can build compliance into every layer of digital transformation.

Through real-world case studies and expert perspectives from industry leaders representing Agilent Technologies, Arcadis, Caliber Technologies, Eli Lilly and Company, GSK, Merck KGaA, ReveonAI, Seeq Corporation, STADA, Takeda, Teva Pharmaceuticals, and others, attendees will gain practical strategies for creating trusted, resilient, data-driven operations.

From teams just thinking about adopting new technologies to those already scaling them, this track pushes past the surface level. Whether navigating digital twins, Quality 4.0, AI governance, cloud collaboration, cybersecurity, or advanced manufacturing compliance, attendees will leave with deep, actionable insights. Plus, engage in networking afterward to exchange strategies and connect with other forward-thinking professionals.

Join the Conversation in Berlin

The 2026 ISPE Pharma 4.0™ and Biopharma Conference offers a unique opportunity to learn from experts shaping the future of pharmaceutical manufacturing, quality, and compliance.

The Pharma 4.0™ Compliant by Design track showcases how organizations are transforming regulatory expectations into strategic advantages through digitally enabled quality systems, trusted data architectures, and intelligent operations.

Join industry leaders in Berlin, Germany, or virtually on 10-11 December 2026.

Learn more and register today.