UDI Implementation 2015

Topics

• The three locations for UDI: direct marking, labeling, and packaging
• Distinguishing among identification, tracking, and tracing
• The UDI form including the required elements and the optional elements
• When a UDI is required, including the exceptions
• When a new version of a model requires a new UDI
• The data elements required for FDA’s global database (GUDID)
• Implications for FDA inspections
• Changes required in the Quality Management System including QSR, MDRs, etc

Who should Attend

• Design engineers
• Regulatory managers
• Project managers
• Labeling specialists
• Quality engineers
• Quality managers
• Complaint handling and MDR specialists