2018 - FDA: UDI and GUDID Compliance

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
• 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
• Walk through the planned timeline for proposed FDA UDI regulations
• Compliance dates and expectations for UDI requirements affecting all classifications of devices
• Evaluate the benefits of implementing bar-coding using GS1 standards
• Understand how labelling systems can remove the perceived complexities of FDA’s UDI regulations
• Direct Marking of Devices
• Convenience Kits and FDA’s position for meeting UDI requirements
• Data submission requirements
• Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with an identifier
• GUDID provides two options for submission of device identification information
• Learn how to implement UDI with minimal impact on your organization
• Impacts on labellers and establishments and meeting FDA’s compliance deadlines
• Device Identifiers vs. Production Identifiers: What goes into each one?
• Frequently Asked Questions and Next Steps
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:
• All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of FDA’s Unique Device Identification Final Rule
• CRO’s
• Regulatory Affairs/RA Specialists
• Clinical Affairs
• Project Leaders for UDI Compliance
• Quality Control/Quality Assurance
• Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services
• Consultants
• Manufacturing
• Labeling Operations
• Auditors
For more detail please click on this below link:
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