01:00 PM | 02:00 PM - EST DURATION: 60 MINUTES
Live webinar on "Implementing a Unique Device Identification (UDI) System - Issued on September 24, 2013"
DESCRIPTION This presentation is intended to provide an opportunity to get familiar with how to implement a unique device identification (UDI) system and to discuss good practices compliant with the UDI final rules, finally issued on September 24, 2013. This presentation is further intended to help you effectively implement a UDI system applicable to your device types. In particular, new changes in the final rules will be discussed, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements. In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution. According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology. If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself. The speaker will present good practices of implementing the relevant and applicable UDI system requirements in a CAC-SI manner. Areas Covered in the Session: Statute(s) and Regulations Definitions UDI History UDI Final Rules: Technical Requirements and Changes Made When to Use a UDI and When to Discontinue Its Use UDI System Requirements including Technical Standards Requirements for a Unique Device Identifier FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
UDI Rules: Applicability Live One Dial In - One $189Attendee One Dial In Unlimited attendance (To be arranged in a $249Conference room/Meeting room. Note : Only One Dial In Allowed)
Combo Combo 1 (One Dial In - Unlimited $329attendance + On Demand Recorded Session) Combo 2 (One Dial In - Unlimited $349 attendance + Training CD)
Recorded On Demand ( 90 Days of online $289Streaming access available after the live session ) Play Back Unlimited Views ( Recorded file $319 available for download after the live session ) Get Training CD $359
UDI Rules: Exceptions and Alternatives Compliance Dates for the Applicable Requirements Over Seven (7) Years Device Identifier Formats including Dates Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes) Impact of the Final Rules to Many Business Areas/Processes Changes in Device Design, Documentation and Manufacturing Processes Good Practices: Practical, Actionable, and Sustainable Solutions/Strategy Conclusion Who Will Benefit: R&D Regulatory Affairs Quality Regulatory Compliance Clinical Affairs Consultants Legal and Compliance Officers Marketing Professionals Senior Management Anyone Interested in the Subject
Multiple Location $109 Multiple location 9 - Up to 5 Dial in $499 allowed
Webinar Includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 60 Minutes Live Presentation Certificate of Attendance
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