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Recorded Webinar
UDI and GUDID - The Unique Device Identification and the Global Unique Device Identification Database : The FDA Plan and Your Requirements
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
UDI is for real! If you have not yet started your UDI compliance plan, you are already behind in your compliance efforts.
In this Webinar we will define what a “UDI” is and is not. We will review how UDI applies to your device and we will discuss compliance dates. In addition we will review a sample UDI label and discuss how it can be applied to your labeling. Does a UDI have to be actually on your device?
FDA has authorized certain organizations to issue UDI’s. We will identify those organizations and discuss how to approach them.
Finally we will discuss GUDID, how FDA is using it and how device manufacturers enter their information and utilize the data base.
This regulation is being implemented as we speak. FDA Investigators will cover it during device inspections. Are you ready to show FDA your UDI compliance plan?
Key goals of the webinar will include learning:
- Understand the specifics of what is a UDI
- Know the FDA timeline for implementation
- Know how to get a UDI issued for your firm
- Know when your device will need to have a UDI
- Know what GUDID is
- Know how to enter into the GUDID system
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