Two featured speakers, Gilad Langer, PhD, Industry Practice Lead at Tulip, and Francesc Garrido, Life Science Quality Advisor at Ambit Iberia, offer complementary perspectives on this challenge. Their sessions focus on moving beyond theory to practical implementation—showing how digital tools, when designed and governed correctly, can actively strengthen compliance while enabling speed and scalability.
Below, learn more about the key insights they will share and why this conference is a must-attend for leaders in manufacturing, quality, validation, and information technology (IT).
Validation 4.0 in Practice: Enabling Connected Frontline Operations
In this session, Gilad Langer, PhD, introduces Validation 4.0 as a practical way to implement validation in the context of a frontline operations platform—not as theory, but through a concrete case. Most of the talk centers on how Eli Lilly and Company built, implemented, and deployed a digital logbook solution across multiple sites to transform paper to digital and instrument the way people do their work. The key benefit he underscores is that compliance becomes seamless, and by adopting Validation 4.0 principles, organizations can implement and deploy digital tools at a speed not seen before.
Langer underscores that the real payoff is seamless compliance—not as an afterthought, but as a natural outcome of how the digital logbook and frontline operations platform are built and used. By adopting Validation 4.0 principles, organizations can implement and deploy digital tools at unprecedented speed while keeping compliance intact, because the controls and records are instrumented into day-to-day work rather than bolted on through paper and procedural workarounds. The session illustrates how this approach removes friction, sustains inspection readiness, and turns validation into an enabler of scale rather than a bottleneck.
Key takeaways include:
- How applying Validation 4.0 principles enables the faster implementation and deployment of digital tools without compromising compliance
- Real-world lessons from building, implementing, and scaling a digital logbook solution across multiple sites
- Why compliance becomes more seamless when validation is embedded into digital workflows, rather than managed through paper-based processes
- How frontline operations platforms can instrument the way people do their work, supporting consistent execution and inspection-ready records
By showing what Validation 4.0 looks like in practice, this session offers a blueprint for organizations ready to modernize operations while staying inspection-ready.
Closing the Gap Between Speed and Sustainable Compliance
This session focuses on helping organizations close the gap between technology speed and sustainable compliance. Garrido addresses a challenge many pharmaceutical companies face today: modern systems are moving faster than the compliance models designed to govern them. Rather than slowing down innovation, this session shows how organizations can evolve their approach to data integrity so that compliance keeps pace with technology—without increasing operational burden.
A central theme of the session is the shift away from manual, paper-heavy audit reviews toward objective-based and automated controls. Garrido explains how organizations can structure effective governance between quality assurance (QA) and information technology (IT) to reduce friction rather than create it. By aligning these functions around a shared objective, compliance becomes more consistent, less reactive, and easier to sustain over time.
The session also highlights how small, practical technical decisions—such as user role design, privilege management, single sign-on strategy, and timeout settings—can have an outsized impact on inspection robustness. Garrido emphasizes practical implementation that attendees can apply immediately. By focusing on risk-based prioritization and embedding controls directly into system design, organizations can avoid repeated remediation cycles and move from compensating procedures to proactive control.
Attendees will learn how to:
- Move from manual, paper-based audit reviews to automated, objective-based controls
- Structure QA-IT governance to reduce friction and support shared accountability
- Use risk-based prioritization to focus efforts on high-impact data integrity issues
- Embed data integrity controls into system design, rather than relying on procedural compensation
- Strengthen inspection readiness with minimal, targeted technical configuration changes
The ultimate goal, Garrido emphasizes, is to move organizations from reactive compliance to proactive control—reducing inspection risk, avoiding repeated remediation cycles, and creating systems that are compliant by design.
Why These Sessions Matter—Together
Langer and Garrido’s messages converge on a critical theme: digital transformation and compliance are not opposing forces when systems are designed thoughtfully.
- Validation 4.0 enables organizations to adopt modern tools at the speed business demands
- Embedded data integrity ensures those tools remain robust, inspectable, and sustainable
- Alignment between operations, QA, and IT is essential to making both possible
Together, these sessions reflect the broader value of the 2026 ISPE Europe Annual Conference—offering concrete strategies, real-world examples, and immediately applicable guidance for pharmaceutical professionals navigating digital change.
Join the Industry in Copenhagen—or Virtually
Taking place 20–22 April 2026 in Copenhagen, Denmark, and virtually, the 2026 ISPE Europe Annual Conference is one of ISPE’s largest global events of the year. It brings together experts across manufacturing, quality, validation, engineering, and digital transformation to address today’s most pressing operational and regulatory challenges.
Whether modernizing legacy systems, deploying new digital platforms, or rethinking your data integrity strategy, this conference is designed to help deliver measurable value.
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