- TypeWebinar
- Location Aurora, Colorado 80016,Colorado,United States
- Date 31-05-2018
Education/Teaching/Training/Development
Business Development
Medical/Healthcare/Hospital
OVERVIEW
The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule. Understand the significance of UDI, GS1 standards, and the GTIN (Global Trade Item Number) which are already recognized across the healthcare industry as a unique identifier of medical devices, surgical products and healthcare supplies. The GS1 GTIN used for device identification, along with Production Information (PI) supports the FDA UDI regulation. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception from some or all of the requirements of the final rule. The UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture technology. Device labellers must submit information concerning each device labelled with a UDI to FDA’s Global Unique Device Identification Database (GUDID). The UDI is required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. Medical device records throughout the required device recordkeeping and reporting systems will have to include the UDI. In addition, the final rule establishes accreditation requirements for organizations that issue UDIs and establishes the conditions for when FDA might act as an issuing agency. Depending on the risk of the device, labellers will have from 1 to 7 years to comply with the UDI system.
WHY SHOULD YOU ATTEND
This webinar will provide valuable and additional insight and an overview for the medical device and IVD companies involved in establishing and maintaining a state of compliance and meeting compliance deadlines for UDI.
AREAS COVERED
LEARNING OBJECTIVES
This webinar provides an understanding of UDI in practical terms and also explains what the compliance expectations for UDI are.
WHO WILL BENEFIT
Employees and personnel who will benefit include:
For more detail please click on this below link:
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Know about the FDA UDI compliance requirements. Also understand the history and features of UDI to meet the requirements efficiently.
Training Doyens 26468 E Walker Dr,Aurora, Colorado
+1-720-996-1616