CASE 1
Accountable project manager FDA UDI Project including all aspect of the implementation.
Including early stage investigation, initial scoping and brief description, setting up project governance, budget, regulatory interpretation, implementation of GS1 standards, implementation of data and upload system to GUDID, update and implementation of global label print system, SOP and guideline updates and all other aspect in a major regulatory implementation project.
Balancing organizational fit within IT-, operational/supply chain- and regulatory strategy.
CASE 2
Full implementation of Labelling software system.
Including fit to current architecture, processes (QMS) and technical setup and configuration
CASE 3
End2End Labeling Program - Streamline Labeling from R&D to printing to end of life for medical devices manufacturer.
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