Source: https://www.complianceonline.com/udi-implementation-webinar-training-703588-prdw?channel=trainingregistry
Timestamp: 2019-03-21 12:36:45
Document Index: 139260333

Matched Legal Cases: ['art 803', 'art 806', 'art 814', 'art 820', 'art 821', 'art 822']

UDI Implementation | FDA Medical Device Regulations : Compliance Training Webinar (Online Seminar) - ComplianceOnline.com
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This webinar on UDI implementation will discuss the new requirements set by FDA for Unique Device Identification. Attendees will learn to overcome hurdles in implementing the new process and learn best practices too.
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.
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
When a new version of a model requires a new UDI
Changes required in the Quality Management System including QSR, MDRs, etc.
This webinar will benefit the professionals working in medical device industries.
Complaint handling and MDR specialists
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.