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UDI Has Gone Global - A Discussion of Requirements, Challenges & Opportunities
Regulators in many countries agreed on a set of principles for building a harmonized Global UDI system throughout the medical device supply chain. Today, variances across jurisdictions in UDI medical device regulations have impacted the healthcare supply chain and can make implementation more challenging for manufacturers. Learn how to overcome these challenges and to take advantage of the opportunities a Global UDI system brings to manufacturers and hospitals.

This webinar will discuss:
• The importance of the UDI device triggers, data quality requirements and validation rules.
• Master data management and how to support data registration to numerous regulatory databases.
• Maintaining globally compliant labels and the impact of regulator and manufacturer actions on the adoption of UDI by across the device ecosystem.
• Ideas to reduce variability and increase the value of the device label as a communications tool.

May 13, 2021 11:00 AM in Eastern Time (US and Canada)

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Speakers

Terrie Reed
Director Partner Relationships @Symmetric Health Solutions
In her role as Director, Partner Relationships at Symmetric Health Solutions Ms. Reed continues to advance the original vision of the UDI system working with Symmetric customers and partners to ensure timely and accurate access to master device data for use by supply chain professionals, clinicians, and researchers. Ms. Reed is former FDA CDRH Associate Director of Informatics and former FDA Senior Advisor for UDI adoption. At FDA she led the cross-disciplinary UDI team that established the initial UDI regulatory policy, designed, and rolled out resources now used across stakeholder groups as a means to transform the tracking of device-related patient procedure information.
Ardi Batmanghelidj
President @Innovatum
Over the past 30+ years, Ardi Batmanghelidj has held several leadership positions in the software industry. Since 1994 the concentration of Ardi’s work has been in the Life Science vertical with emphasis on regulatory compliance. His extensive hands-on experience implementing and integrating ERP, MES, and labeling systems benefits Innovatum customers both in the capabilities of Innovatum software and during the implementation phase of any project. Ardi is a published author and sought after speaker at industry forums, providing expert guidance to the FDA and manufacturers in the area of master data management, labeling and barcoding. Ardi Batmanghelidj holds a Bachelor’s degree in Economics and Political Science from the University of Massachusetts. He has additional IT certifications from the Computer Processing Institute, Boston University and The Worchester Polytechnic Institute.
Pete Alvarez
Senior Director, Identification & Data Strategy GS1 Healthcare @GS1 Global Office
Pete is part of the GS1 Global Office healthcare team and has been with GS1 since 1999. He is a subject matter expert on GS1 standards for Automatic Identification and Data Capture (AIDC), master data and data quality, the Global Data Synchronisation Standard (GDSN), product classification standards, and the GS1 Digital Link standard. He is passionate about the work GS1 is doing to improve patient safety, medical outcomes and supply chain efficiency.