Working with the Oracle Agile team, Inspirage has developed a solution to help companies with UDI Compliance leveraging the Agile solution. Learn more about how Inspirage can help your company meet these requirements.
Register for the Webinar
Date Thursday, August 15, 2013
Time 1:00pm to 2:30pm CST
The FDA is in the final stages of implementing Unique Device Identifier (UDI) which will place requirements on Medical Devices to have a label containing Device Identifier data and Production Identifier data. The UDI data must be submitted to the FDA via their submittal system: all Class 3 devices must be compliant by summer of 2014 and all Class 2 devices must be compliant within two years of that.
Please join us for a LIVE Webcast on Thursday, August 15 @ 1:00pm CT where Todd Hein, Life Sciences Industry Product Specialist from Oracle and Mike Torek, Sr. Practice Director from Inspirage, highlight the benefits of utilizing Oracle applications and the Inspirage designed solution.
- Extract, standardize, and aggregate legacy product attributes
- Manage all Device Identifier attributes within an FDA auditable archive under 21 CFR Part 11 change control
- Manage packaging hierarchies dependencies
- Associate Device Identifiers with Device Master Records
- Enable HL7 SPL XML submittal to the FDA
- Facilitate data flows to the downstream Supply Chain/Manufacturing system for consumption onto the UDI label itself.
Who should attend?
Medical Device Professionals with responsibilities in: Quality, Compliance, Regulatory, Analytics, Reporting, IT