DIGITAL CMC SUMMIT / ON-DEMAND SESSION

Digital CMC, Quality & Compliance

Learn how new data management methods are helping quality teams reshape their role in drug development.

Session highlights & insights

New data integrity paradigms driving an industry shift from compliance-focused quality to “quality culture.”

Best practices for embedding quality and compliance in digitally enabled CMC workflows and outputs.
Key organizational steps that drug development teams can take to build digital-ready, quality-focused CMC programs.
Why successful digital CMC initiatives need to focus on both patient-centric outcomes and user-centric priorities.

Session Speakers

Meet the group transformation experts who share their insights and expertise in this on-demand session.

Kir Henrici Headshot

Kir Henrici

CEO, The Henrici Group

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Jack Garvey

Jack Garvey

Managing Partner, Compliance Architects LLC

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lukefull

Luke Guerrero

COO, QbDVision

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SUMMARY

Reimagining the connection between quality, compliance, and CMC

Across the life sciences, quality organizations are reaching a crossroads. The traditional document-driven compliance culture is being challenged to evolve beyond reactive quality verification and transform into a data-powered driver for modern scientific enterprises.

But for many of those organizations, the effort to digitize quality management has been slowed and delayed by a range of factors – from sticky legacy methods, to regulatory blur, to timeline pressures. Too many “digitized” drug developers are seeing their quality teams drift back to paper, and to their default role as compliance cops.

So how can today’s life sciences organizations break through this challenge and drive sustained, effective transformation – especially when they’re focused on paper-dependent functions like quality? 

Two veteran quality and compliance specialists took the stage to share their views on that question at the 2022 Digital CMC Summit. Stream this on-demand feature to learn: 

  • Why the future of quality is taking shape at the intersection of data governance, data culture, and quality culture
  • How digitally-savvy drug developers are adopting this new quality paradigm from the start, and building it into their CMC programs from the ground up
  • Where organizations need to focus to ensure their digital investments make a lasting impact on the growing intersection of data management, quality oversight, and compliance

Sign up to watch the full session, including in-depth presentations from two leading quality and compliance experts and an interactive live Q&A.

Stream these exclusive insights from the 2022 Digital CMC Summit.

Sign up to watch eight full sessions captured live at the 2022 Digital CMC Summit — including in-depth presentations, Q&A, and moderated deep-dives into our industry’s digital future.