UDI Implementation

Why Should You Attend:

The US FDA issued the final regulations for Unique Device Identification (UDI). Now is the time for manufacturers to start implementation planning.

UDI implementation for a company will have three major elements:

• Putting the required information on the device label, the device packaging, and, in some cases, on the device itself
• Loading all the required information into the FDA-CDRH database called GUDID
• Revising all the affected procedures

The UDI regulations include changes to almost every part of the device regulations – Part 803 (Medical Device Reporting), Part 806 (Medical Devices; Reports of Corrections and Removals), Part 814 (Premarket Approval of Medical Devices), Part 820 (Quality System Regulation), Part 821 (Medical Device Tracking Requirements), and Part 822 (Postmarket Surveillance).

This webinar explains the issues involved in UDI implementation so you can develop your implementation plan. The implementation timing is complicated because it is inferred by device class and other characteristics, such as whether or not the device is classified as life-saving or life-sustaining. The first compliance date was September 24, 2014 with more devices following in subsequent years. Most companies, especially small manufacturers, should not wait. This means implementation for all products to avoid having to maintain more than one system.

You will learn the UDI structure (required and optional elements), where it is placed (device, base package, and packaging configurations), the required date format, and the Global Unique Device Identification Database (GUDID) data elements. In addition, the webinar explains changes to your procedures.

Areas Covered in the Webinar:

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

Who Will Benefit:

This webinar will benefit the professionals working in medical device industries.

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

Instructor Profile:

Daniel O' Leary is president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Mr O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma Black Belt; and certified by APICS in resource management.

Follow us :