Implementing a Unique Device Identification (UDI) System - Issued on September 24, 2013 2014 is a webinar that covers topics such as:
- Definitions
- Statute(s) and Regulations
- UDI Final Rules: Technical Requirements and Changes Made
- UDI 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)
- Good Practices: Practical, Actionable, and Sustainable Solutions/Strategy
- Changes in Device Design, Documentation and Manufacturing Processes
Implementing a Unique Device Identification (UDI) System - Issued on September 24, 2013 2014 is intended for:
- Regulatory Affairs
- R&D
- Regulatory Compliance
- Quality
- Consultants
- Clinical Affairs
- Marketing Professionals
- Legal and Compliance Officers
- Senior Management
