Developing a Global Unique Device Identification (UDI) Program

12.0
RAC Credits
Wednesday, 20 October 2021 (9:00 AM) - Thursday, 21 October 2021 (5:00 PM) Eastern Time (US & Canada)

Unique Device Identification (UDI) is much more than a project that can be handled just by a competent project manager and a couple of data-entry personnel. Rather it is a process that impacts all business functions and aspects of the quality management system and requires buy-in and support from all levels of the company. And as the use of UDI expands globaly, it is increasingly important that your UDI program be sustainable and flexible to allow for compliance to multiple regulations that may consist of conflicting requirements.

 

In order to create a sustainable and compliant global UDI program, it is essential that you understand the:

• Intent of UDI

• Key similarities/differences between the various regulations

• Requirements for specific products (i.e., implants, SUI, IVD, software)

• Critical aspects of the regulations

• Application of the regulations to your products.

 

Whether UDI seems a minor hurdle or an insurmountable obstacle to you, without a solid understanding of what is required, you will not clearly see what lies ahead and undoubtedly experience unnecessary complications and delays. This two-day workshop will provide an overview and comparison of UDI requirements in the US, EU and other countries, and will include a breakdown of the required data elements, a review of the implementation timelines, overview and implications of direct marking requirements, the planning process for implementation and a discussion on the challenges already faced and lessons learned.

 

If you are already familiar with UDI, parts of this workshop will provide a review for you, however your comments and experiences will contribute to the discussion and benefit those attendees who are new to UDI. If you are not familiar with UDI, this session will answer many of the questions you didn’t know you had while not overwhelming you.

 

Areas Covered:

• Comparison of Global UDI Regulations

• Labeling Changes

• UDI Data Elements – Collect, Control and Manage

• Overview of EUDAMED

• Incorporating UDI into the Quality System

• Verification of UDI Carrier

• UDI Planning & Implementation Checklist

Speakers:


Lena Cordie-Bancroft, President/Principal Consultant, Qualitas Professional Services, LLC

Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Services, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems; incorporate processes to comply with FDA, EU and other international regulatory requirements related to quality systems, risk management; and regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is a member of ASQ, and as a member of Regulatory Affairs Professionals Society (RAPS), serves as the chairperson for the Twin Cities Chapter, is a member of the RAPS European Committee (REC), and a leader of the UK Local Networking Group.

Maria Vrabie, Director, Regulatory & Clinical Affairs, Abbott Rapid Diagnostics Business

 
Pricing

3 December 2020 – 20 September 2021: Early Bird $800 Members | $900 Nonmembers

21 September – 20 October 2021: Regular $900 Members | $1,000 Nonmembers


Cancellation
Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.

Additional Information (who to contact, special instructions)

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.

 

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200