Dates/times:
Tuesday, June 21 2016 at 01:00 PM (Get Tickets)
Location:
webinar
USA
Newyork, NY 10036
Event Description:
Unique Device Identification (UDI) Compliance
Location: Attend Live Webinar
Dates: 21-June-2016: 1:00 PM EST
Duration: 60 Mins
Speaker:David R. Dills
David R. Dills, is an independent Global Regulatory Affairs & Compliance Consultant and has an accomplished record with more than 26 years of experience in regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification.
Course Description:
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 labelers must submit information concerning each device labeled 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 record-keeping 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, labelers will have from 1 to 7 years to comply with the UDI system.
Course Objective:
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
Course Outline:
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 labeling 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 labelers and establishments and meeting FDA’s compliance deadlines
Device Identifiers vs. Production Identifiers: What goes into each one?
Frequently Asked Questions and Next Steps
Target Audience:
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. 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
Please Click hear for More Information & Registaration
Thank you & Regards,
Sean Sharpe,
Training Manager,
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