President Qualitas Professional Services, LLC Victoria, Minnesota, United States
You can register for this Pre-Conference workshop until Thursday 22 October via the RAPS Euro convergence website: https://www.raps.org/europe-2020/register. Once you have registered you will receive an email with the webcast link for the meeting.
Unique Device Identification (UDI) is more than a project that can be handled 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 into other global markets, it is increasingly important that the 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.
UDI may seem like a minor hurdle or an insurmountable obstacle to you, but without a solid understanding of what is required, you will not clearly see what lies ahead and undoubtedly experience unnecessary complications and delays. This 1-day workshop will provide an overview and comparison of UDI requirements in the US and the EU, including 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 ________________________________________
8:30 – 10:00 • Welcome & Introduction • Intent of Unique Device Identification • Review of IMDRF UDI Requirements • Comparison of US to EU to IMDRF • Update on Progress of Other Global UDI Requirements/Regulations