Unique Device Identification (UDI) Final Rules Overview 2013

Topics

• Definitions
• Applicable Statute(S), Regulations and Enforcement Authority
• UDI Final Rules: Technical Requirements and Changes Made
• UDI Development History
• UDI System Requirements including Technical Standards
• When to Use a UDI and When to Discontinue Its Use
• FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
• Requirements for a Unique Device Identifier
• UDI Rules: Exceptions and Alternatives
• UDI Rules: Applicability
• Device Identifier Formats including Dates
• Compliance Dates for the Applicable Requirements Over Seven (7) Years
• Impact of the Final Rules to Many Business Areas/Processes
• Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
• Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
• Changes in Device Design, Documentation and Manufacturing Processes
• Conclusion

Who should Attend

• Regulatory Affairs and Compliance Professionals
• R&D Scientists, Managers, Directors, and VPs
• Quality Professionals
• Clinical Affairs Professionals
• Legal and Compliance Officers
• Consultants
• Senior Management
• Marketing Professionals
• Anyone Interested in the Subject