Hands-On Learning for a Changing Industry: Explore the Interactive Workshops at the 2026 ISPE Annual Meeting & Expo

That is precisely the focus of the Interactive Workshops at the 2026 ISPE Annual Meeting & Expo, taking place 18–21 October in Washington, D.C., USA (and virtually). Included with the In-Person All Access Pass, these immersive three-hour sessions provide participants with hands-on learning experiences designed to address some of the industry’s most pressing challenges and opportunities.

Running from 1300–1600 ET, the workshops bring together industry leaders, regulators, and subject matter experts to facilitate collaborative learning and actionable problem-solving. Whether your focus is contamination control, sustainability, manufacturing network standardization, digital transformation, or organizational agility, these workshops offer practical insights that go beyond traditional conference sessions.

Turning Annex 1 Compliance into a Strategic Design Advantage

The workshop “Annex 1 in Action: Designing Facilities That Reduce Risk” addresses one of the industry’s most significant regulatory priorities: implementing Annex 1 principles effectively within facility design and operation.

Led by Mark Muench (AbbVie), Keith Beattie (Energy Efficiency Consultancy Ltd.), and Norman Goldschmidt (Genesis AEC), this highly interactive session helps participants move beyond compliance-focused thinking and explore how Annex 1 requirements can drive smarter facility design.

Through real-world case studies and expert-led discussions, attendees will examine:

• Proactive contamination control strategy (CCS) integration
• Holistic quality risk management approaches
• Optimized process flow design
• HVAC and barrier technology strategies
• Integrated monitoring systems
• Sustainable air handling solutions

The workshop also reviews common regulatory observations and challenges, including gaps in environmental monitoring programs, CCS implementation, and risk management execution. Participants will leave with practical strategies for designing new facilities and major upgrades that reduce contamination risks while improving operational efficiency and sustainability.

For professionals involved in facility engineering, quality, validation, and manufacturing operations, this session provides valuable guidance on translating Annex 1 expectations into tangible business and operational benefits.

Advancing Sustainable Manufacturing Through Data and Innovation

Sustainability continues to move from a corporate aspiration to a business imperative. The workshop “Accelerating Innovation in Sustainable Sourcing and Manufacturing” explores how organizations can leverage digital tools, data intelligence, and supply chain collaboration to achieve sustainability goals while maintaining performance and resilience.

Facilitated by Mitch Cook, PhD (Deloitte), Krista McGuire, PhD (Pfizer), and Jennifer Aurandt-Pilgrim, PhD (Marquis Energy), this workshop focuses on the growing intersection of sustainability, manufacturing, and advanced analytics.

Participants will examine how artificial intelligence, machine learning, product lifecycle data, and market intelligence can support:

• Sustainable raw material sourcing
• Emissions reduction initiatives
• Supply chain resilience
• Cost optimization
• Sustainable-by-design manufacturing strategies

A unique component of this session is the inclusion of perspectives from upstream commodity suppliers that are developing low- and negative-emission raw materials. Attendees will gain insight into how sustainability innovations are being implemented across industries and how pharmaceutical organizations can create mutually beneficial commercial partnerships.

Designed for leaders and emerging professionals involved in sustainability, digital transformation, manufacturing operations, and supply chain management, the workshop offers practical frameworks for accelerating sustainability initiatives while delivering measurable business value.

Building the Standardized Manufacturing Networks of the Future

As pharmaceutical companies expand globally and seek greater operational flexibility, standardized manufacturing networks (SMNs) are becoming an increasingly important strategic model.

The workshop “From Single Sites to Standardized Manufacturing Network” explores how organizations can transition from isolated manufacturing operations to globally integrated networks that support agile scale-out, rapid technology transfer, and resilient product supply.

This expert-led session features insights from leaders representing:

• Genentech/Roche
• Merck
• Novo Nordisk
• US Food and Drug Administration (US FDA)

Participants will learn how organizations are implementing approaches such as:

• Modular manufacturing
• Copy-paste facility concepts
• Sister-site strategies
• Fleet-based operations
• Standardized operating philosophies

Real-world case studies will demonstrate how companies maintain quality, consistency, and GMP compliance across multiple sites while increasing speed and flexibility.

An especially valuable component of the workshop is its focus on the evolving regulatory landscape. Discussions will explore how regulatory frameworks may support advanced manufacturing models, distributed manufacturing concepts, and highly standardized global networks.

Interactive breakout sessions allow attendees to collaborate on topics including:

• Standardized control strategies
• Digital enablers
• Knowledge management systems
• Post-approval change management
• Accelerated approval pathways
• ICH Q12 implementation tools

For organizations pursuing manufacturing modernization and global operational excellence, this workshop provides practical guidance for designing and governing next-generation manufacturing networks.

Developing the Skills Needed for Pharma’s Future

Success in the pharmaceutical industry increasingly requires adaptability, leadership, and a commitment to continuous improvement. The workshop “The Future of Pharma: Agility, Growth, and Continuous Improvement Strategies” focuses on equipping professionals with the capabilities needed to thrive in a rapidly changing environment.

Featuring a distinguished panel that includes former US FDA regulators, industry executives, quality leaders, and emerging professionals, the session brings together expertise from organizations including Johnson & Johnson, ELIQUENT Life Sciences, ProcellaRX, PQE Group, and Pathway for Patient Health LLC.

The workshop explores three interconnected themes:

• Professional development
• Personal growth
• Social impact

Participants will gain practical insights into leadership, operational excellence, regulatory compliance, and organizational transformation. Through collaborative breakout sessions, attendees will work together to identify improvement strategies that extend beyond compliance and create sustainable value for patients, organizations, and the industry.

This session is particularly relevant for professionals seeking to strengthen leadership capabilities, improve organizational agility, and prepare for the evolving demands of the pharmaceutical workforce.

Driving Validation 4.0 Through Digital Innovation

Digital transformation continues to reshape pharmaceutical operations, and validation is no exception. The workshop “Digital Validation in Practice” demonstrates how organizations can implement Validation 4.0 concepts using AI-enabled tools and modern digital validation platforms.

Led by experts from No Deviation, Kneat, Valkit.Ai LLC, and Takeda Pharmaceuticals International AG, this session takes participants through the full validation lifecycle using two contrasting use cases:

• Validation of a software-as-a-medical-device application
• Calibration of a thermocouple

Rather than focusing solely on AI-generated test cases, the workshop examines how emerging technologies can support validation activities from initial requirements development through defect resolution and quality insight generation.

Attendees will explore:

• Requirements authoring
• Risk assessment
• Test design
• Automated execution
• AI-assisted deviation detection
• Defect management
• Insight generation and analytics

The hands-on format allows participants to work through simplified validation scenarios themselves, providing an opportunity to experience Validation 4.0 capabilities in practice. The session concludes with discussions on governance, data integrity, and regulatory expectations, helping attendees understand how advanced technologies can be deployed responsibly in GxP environments.

Why Attend the Interactive Workshops?

The Interactive Workshops at the 2026 ISPE Annual Meeting & Expo offer far more than theoretical discussions. They provide an opportunity to collaborate directly with industry experts, regulators, and peers while exploring practical solutions to today’s most significant pharmaceutical manufacturing and quality challenges.

Participants will gain:

• Hands-on learning experiences
• Actionable implementation strategies
• Exposure to emerging technologies and approaches
• Insights from regulators and industry leaders
• Opportunities for networking and collaboration
• Practical tools that can be applied immediately within their organizations

From Annex 1 implementation and sustainability to manufacturing modernization, leadership development, and digital validation, these workshops are designed to help professionals build the knowledge and skills needed to succeed in a rapidly evolving industry.

Join ISPE in Washington, D.C.

The 2026 ISPE Annual Meeting & Expo brings together pharmaceutical and biopharmaceutical professionals from around the world to share knowledge, explore innovation, and shape the future of the industry.

These interactive workshops offer a unique opportunity to move beyond discussion and into action, engaging with real-world challenges through collaborative, expert-guided learning experiences.

Learn more and register today.