Search

Home > Voices In Validation > CSV: Excellence and Next Generation Approaches to Quality System Monitoring
Podcast: Voices In Validation
Episode:

CSV: Excellence and Next Generation Approaches to Quality System Monitoring
Category: Science & Medicine
Duration: 00:59:20
Publish Date: 2021-06-29 04:00:00
Description:

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Excellence and Next-Generation Approaches to Quality System Monitoring." This discussion was moderated by Michelle Miller and features Nuala Calnan, Alyce Deegan, and Daniel Caparros.

The discussion will be focused on providing reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enabled facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control.

About the panel:

Michelle Miller

Michelle Miller is Director of Global Validation at Illumina Inc. In this role, Michelle leads the global non-product validation across the company. This includes the strategy and execution of validation for facilities, manufacturing processes, consumables production, quality system, enterprise software, and other systems across all of Illumina. Over the past 12+ years, she has held roles in product engineering, product transfer, validation engineering, and quality assurance, supporting the manufacturing of microarrays, genome sequencing reagents, and consumables.

Nuala Calnan

Nuala is a 25 year veteran of the pharmaceutical industry. Her work as a consultant, academic, author and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), HPRA(Ireland) on patient safety and product quality.

Nuala works with organizations to transform organizational culture, deliver more effective end-to-end risk management, implement knowledge excellence strategies, behavior-based good data governance, and enhance performance management through people.

Nuala co-leads the ISPE Quality Culture Team, is a founding member of the ISPE Knowledge Management Task Team, and an Arnold F. Graves Scholar at TU Dublin, Ireland, where she leads many patient-focused regulatory science research projects at Masters and Ph.D. level.

Alyce Deegan

Alyce has over 20 years of experience in the Pharmaceutical, Medical Device, and Gene Therapy industries. Alyce recently was the CSV Director at SeaGen and the IT Director of Manufacturing and GxP Lab Systems at Juno Therapeutics a CAR-T Cell Therapy Manufacturing Plant located in Bothell, WA. Throughout Alyce’s career, she has held leadership positions in Quality, Validation, and IT at Pfizer, Biogen, and ThermoFisher.

Daniel Caparros

Head of Global Quality Strategy Data and Vendor Management at Merck KGaA, Darmstadt, Germany   Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 
Total Play: 0