Establishing an FDA-Compliant UDI System 2015

Key Topics

• 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, and When to Use a New UDI
• FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
• Requirements for a Unique Device Identifier
• Devices at a Retail Store, Delivered to Health Care Facility, Outpatient Treatment Facility, Nursing Home, Ambulatory Surgical Center, and Hospitals
• UDI Rules: Applicability, Exceptions and Alternatives
• Devices (Single Use, Custom, Intended for Export, Convenience Kits, Combination Products, Medical Procedure Kits and Trays)
• Devices Labeled Prior to Compliance Dates
• When to Request Exceptions and Modifications
• Class I Devices: cGMPs Exempted
• Direct Marking Requirements and Revised Changes
• Which Devices Not Required to Have a Production Identifier
• Compliance Dates for the Applicable Requirements Over 7 Years
• Requirements for Stand-Alone Software
• Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
• Device Identifier Formats including Dates
• Changes in Device Design, Documentation and Manufacturing Processes
• Impact of the Final Rules to Many Business Areas/Processes
• Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast

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