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Preparing for FDA's Unique Device Identification Rule

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This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Speaker
Instructor: Daniel O Leary
Product ID: 702594
Training Level: Intermediate to Advanced

Course "Preparing for FDA's Unique Device Identification Rule" has been pre-approved by RAPS as eligible for up to 1.5 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

In July 2012, the FDA issued the draft regulations for Unique Device Identification (UDI). This draft regulation describes new requirements of labeling medical devices as well as providing information to a new database that FDA maintains.

This webinar explores the explicit requirements as well as the hidden requirements in the draft UDI regulation.

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

Areas Covered in the Webinar:

Who will Benefit:

This webinar is for people involved in understanding, analyzing, and implementing the UDI regulations.

People in the following roles can especially benefit from the knowledge in this webinar:

Instructor Profile:

Dan, 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 aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Topic Background:

UDI is the first major change to many of the implementing regulations in recent years. While the draft is still in the comment period, it is very unlikely that it will undergo significant changes before the final regulation. Congress passed legislation in 2007 directing the FDA to develop unique device identification for medical devices. In June 2012, Congress passed another law directing the FDA to publish a draft rule by the end of 2012, publish the final rule no later than 6 months after the close of the comment period, and implement the final regulations for specified devices within two years.

The draft UDI regulations will require major changes for device manufacturers. You must change your quality management system for the new requirements. These changes fall into two categories.

In the first category, you will implement specific, but broad based, requirements for the UDI system. These will include, but extend far beyond, Part 820. For example, you will implement the new Part 830, revise your medical device reporting procedure, update your corrections and removals procedures, and change your design control, labeling, device master record, device history record, and complaint procedures.

In the second category, you will implement specific, but narrow requirements for each device and packaging level. For example, if, today, you decide to ship product in packages of five, you do not have to inform FDA, the listing doesn’t change. However, the same new packaging will create a new UDI at the packaging level, so you must inform FDA!

While the regulation appears simple on the surface, but there are many potential problems and traps. It appears you will just change the device label by adding new information and provide some data to FDA for their new database. However, you will need a new UDI for each packaging level. A device will have a UDI, but each packaging level needs a new UDI; a package of one has a different UDI than a package of five!

Moreover, the UDI must change when the device design changes, there is a new indication for use and, potentially, for each change in the Device Master Record. You will need to evaluate each change to see if it creates a new version or model; each one requires a new UDI. If you change any of the following, you need a new UDI:

Successful manufacturers will quickly integrate the new UDI regulations into their existing programs. Because of the benefits to certain customer, early adopters can gain a competitive advantage. You need to start planning now for the new regulation. For example, the changes in labeling will require new responsibilities for the designated individual who verifies the labels. Less obvious is the change in design input. Manufacturers may need to invoke the design change requirements, 820.30(i), to implement the new UDI requirements; the device label will have major changes!

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

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