Breakout

Breakout #2: Managing Data Integrity Across the Total Product Lifecycle

Wednesday, April 22, 2026

2:40 PM - 3:25 PM East Coast USA Time

Location: Franklin CD - 2nd Floor

Moderator(s)

Sean Boyd

Vice President
QualityHub, Inc.

Speaker(s)

Donna M. Haire

CEO / COO / Board Director
The Eriah Group / FluoGuide / Sedana Medical / BioPorto

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Josh Nipper

Director, PreMarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA

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This session will bring together industry and regulator representatives to share perspective on managing data across the product lifecycle. Experts will share broad perspectives on data generation, analysis, management, monitoring and audit frameworks necessary to ensure the reliability and robustness of data generated within your organization and from trusted suppliers. Participants will learn of regulatory requirements, how to address vulnerabilities, and hear perspective from FDA on it’s ongoing data integrity activities and actions. Check it out this session to ensure your data is reliable and fit-for-purpose through real-world case studies and practical application.