2022 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.”
Session Speakers
Meet the group transformation experts who share their insights and expertise in this on-demand session.
Kir Henrici
CEO, The Henrici Group
Kir Henrici
CEO, The Henrici Group
As a life science consultant working domestically and internationally for over 12 years in support of quality and compliance in pharma and biotech, Kir Henrici’s work in holistic quality systems and data integrity remediation is unparalleled. 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.
Jack Garvey
Managing Partner, Compliance Architects LLC
Jack Garvey
Advisor | Managing Partner, Compliance Architects LLC
Jack Garvey is a life sciences industry thought leader and operations veteran. As both a chemical engineer and licensed attorney, Jack brings deep insight into industry issues at the intersection of law, regulation, science, and business. Embracing innovation and advocacy, Jack’s ability to resolve the problems faced by regulated industry is unparalleled.
Luke Guerrero
COO, QbDVision
Luke Guerrero
COO, QbDVision
SUMMARY
Reimagining the connection between quality, compliance, and CMC
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.
