This webinar will cover the proposed EU and UK UDI requirements and highlight the primary similarities and differences with the US FDA’s UDI System regulations (including GUDID).
The discussion will include:
- Overview of the EU UDI System
- Obligations of responsible parties and proposed implementation timelines
- Major similarities and difference with the US UDI System
- Overview of the UK NHS “UDI-type” requirements
- Live Q & A session
Who should attend?
- UDI Team Leaders/Members
- Regulatory Leaders/Teams
- Manufacturing, Operations and Supply Chain Logistics
- UDI IT Support
- Distributors with UDI Submission Responsibilities
About the Presenters:
Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.