Carol - hello - this could be a web site all on to its own.
We are tackling this problem too and it is quite complex. You mentioned two of the possibilities. There are current considerations for: UDI, GMDN, UMDNS, UNSPSC, GTIN and GLN. Some are voluntary, some mandatory, some are US-based, some are required for international shipments. Each has its own format and own location on paperwork, packaging or both. Etc. We are developing a spreadsheet to cover these variables including the deadlines.
I suspect that we will calling each organization and would also love to know of a resource.... I'll be checking after travel. For packaging concerns and someone who also knows UDI, Laura Bix at Michigan State School of Packaging is an excellent resource. MSU has other ressources too.
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Frank Pokrop
Dir. Regulatory Affairs
Carefusion
San Diego CA
United States
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Original Message:
Sent: 06-22-2011 08:15
From: Carol Vierling
Subject: UDI/GS1 Bar Coding
Does anyone know of someone who is knowledgeable of UDI requirements and could perform a gap analysis and develop an implementation plan for a medical device company? It is not the logistics of applying the bar code that is needed but rather an evaluation of multiple systems that would support the information behind the UDI (GMDN codes, GTIN, etc.) A multi-team approach is needed to tackle this project and where to start is the question.
I appreciate your input.
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Carol Vierling RAC
Director, Corporate Regulatory Affairs
Zimmer
Warsaw IN
United States
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