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DCMC Session
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Presentations & Panel Discussion
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Digital CMC, Quality & Compliance | Digital CMC Summit | Presentations & Panel Discussion

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.

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.

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[
The Henrici Group
]

Kir Henrici

Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE — she currently serves on the PDA Regulatory Affairs/Quality Advisory Board.

[
Compliance Architects LLC
]

Jack Garvey

[
QbDVision
]

Luke Guerrero

A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers' CIO Advisory consulting unit.