UDI Labeling 2020 - FDA’s Latest UDI Labeling Requirements Training

Join us for a webinar on September 16 for a discussion of the webinar
The U.S. FDA is well into their long-anticipated Unique Device Identification System. Its purpose is to “establish a system to adequately identify devices through distribution and use”. It requires the development of a unique device identifier (UDI) in plain text and machine readable formats, to be part of the labeling of every medical device.
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
How the New Draft Guidance expands upon the Final Rule.
The two forms of a UDI and clarification on the content of the UDI
The data delimiters that identify specific data elements within the UDI
The order of the data in a UDI and UDI carrier
Speaker:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S.,