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UDI Best Practices - Preparing for Implementation (MFG450P)

Presented by: Dan O'Leary
(*) Single User Price. For multiple users please call 1-844-384-4744
Pre Recorded Webinar
60 minutes
Event Description

Understand the New Regulations for UDI and Plan for an Effective Implementation

The new regulations for Unique Device Identification (UDI) are being phased in. The first two major dates - update quality system procedures and make UDI available for class 3 devices - have passed. While Class 3 devices are important, they are not the vast majority of medical devices being marketed. However, we can learn from experience to date to help plan an effective implementation.

Many companies have failed to comprehend the magnitude of UDI implementation. For example, companies are not sure how many medical devices they make are subject to the UDI rule. When asked how many packaging configurations, such as five in box or ten in a case, for each device, device manufacturers realize they don't know this basic information, and their Management Information System are not structured to easily provide these answers.

A well planned implementation project with sufficient time allowed will help you move from a potential crisis to a smoothly executed result. This webinar by Dan O'Leary will help you plan the major elements of UDI and successfully implement them.

UDI implementation falls under three major categories, each of which has specific tasks. The major categories are: make QMS changes, revise label (or device) information, and load the FDA's database. As an example, revising the label means contracting with a third party to provide required information, determining the data on the device label, and implementing any required date formats.

This session will describe the UDI rule and the most important elements your company must consider, including timelines to implement specific requirements. This program will provide the information to help you determine the applicable elements and when you have to complete them. For each of the major categories, the course breaks them down into component tasks and provides best practices for your consideration.

The session will also include slides containing a checklist of things to consider for UDI implementation. This checklist will also be provided as a separate Word document. Benefits include an understanding of the rule with practical advice for implementation.

In this program, you will learn:

  • The parts of the FDA regulations impacted by UDI and when your revisions are due
  • The required information on the device label and how to format it
  • Determining your packaging configurations and labeling them
  • When a device requires direct marking
  • How to establish the infrastructure to load and maintain FDA's Global Unique Device Identification Database (GUDID)
  • The database elements you need to determine and load
  • Considerations on the method to load the data and the IT implications

This session will benefit all personnel involved in the UDI implementation including:

  • The manufacturing sub-sectors are all medical device manufacturers who market devices in the US, regardless of where in the world the device is manufactured.
  • Quality professionals
  • Regulatory professionals
  • Data analysts
  • IT professionals
  • Design engineers
  • Package and labeling specialists
About Our Speaker(s)

Dan O'Leary | Quality Management SpeakerDan O'Leary
Dan O'Leary is the 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. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including a... More info

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    Event Title: UDI Best Practices - Preparing for Implementation
    Presenter(s): Dan O'Leary

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