FDA: UDI and GUDID Compliance
: 31 May 2018
Sector: Clinical, Pharmaceutical
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.
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.
• Introduction to UDI and History
• Final Rule: UDI regulation
• UDI is a unique numeric or alphanumeric code that consists of two parts: DI and PI
• How GS1 Standards can be used to meet UDI requirements
• Tools and resources, including guidance, available to help you get started
• Gain an understanding of UDI in practical terms
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:
• Regulatory Affairs/RA Specialists
• Clinical Affairs
• Project Leaders for UDI Compliance
• Quality Control/Quality Assurance
• Marketing & Sales
• Distributors/Authorized Representatives
For more detail please click on the below link: