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Update on Unique Device Identifier for Device Manufacturers


Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions.

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    Live Webinar         on
     Update on Unique Device Identifier for Device Manufacturers

     Course "Update on Unique Device Identifier for Device
     Manufacturers" has been pre-approved by RAPS as eligible for
                                                                                            Register Now                         
     up to 1.5 credits towards a participant's RAC recertification
     upon full completion.

    Date & Time:                                                                       Instructor Profile:

     Tuesday, May 22, 2012              10:00 AM PDT | 01:00 PM EDT
                                                                                                    David R. Dills
     Duration: 90 Minutes               Instructor: David R. Dills                               Industry Regulatory &
                                                                                                Compliance Consultant,
     Location: Online                   Price : $245.00   (for one participant)

                                                                                       David R. Dills, an independent
                                                                                       Regulatory & Compliance Consultant
    Overview:                                                                          with more than 22 years of hands-on
    Recent reports identified several potential benefits to widespread                 experience and a proven track
    use of UDI, such as reducing medical errors, facilitating recalls,                 record within the FDA regulated
    improving medical device reporting, and identifying incompatibility                industry, has an extensive
                                                                                       regulatory and compliance
    with devices or potential allergic reactions.
                                                                                       background with Class I/II/III and
                                                                                       IVD devices and managing and
    The reports further indicated that many issues have to be addressed                handling activities within the global
    prior to successful implementation of UDI for devices, including                   regulatory and compliance
    determining the technology needed to utilize UDI effectively,                      landscape. He manages quality,
    identifying the data needed for patient safety; development,                       regulatory and compliance projects
    maintenance, and validation of a central data repository; and                      with multiple competing priorities
    harmonizing UDIs for the international marketplace. FDA is                         having a direct impact on site
                                                                                       operations and commercial
    reconsidering whether some form of unique device identification
                                                                                       opportunities and develops
    (UDI) is warranted for medical devices, given the potential of UDI to
                                                                                       strategies for governmental approval
    help reduce medical errors, facilitate recalls, and other issues                   to introduce new products to market,
    identified from above but also improve inventory control, improve                  provides guidance and direction on
    reimbursement, and reduce product counterfeiting. Once your device                 regulatory and compliance
    is approved, ongoing regulatory requirements fall largely into two                 requirements and prepares/reviews
    categories: labeling and tracking. How does UDI fall into this                     worldwide
    category?                                                                          submissions/dossiers/technical files
                                                                                       and addresses requirements in the
                                                                                       EU, Pacific Rim and The Americas
    Why should you attend:                                                             regarding all aspects of device
                                                                                       commercialization and especially
    Understand how the use of a unique device identification (UDI)
                                                                                       FDA activities. Background
    system may improve patient safety, e.g., by reducing medical errors,
                                                                                       encompasses broad capabilities in
    facilitating device recalls, and improving medical device adverse                  quality systems, validation,
    event reporting. Understand some of the issues associated with the                 regulatory affairs, GxP compliance,
    use of various automatic identification technologies (e.g., bar code,              auditing, interfacing with the
    radiofrequency identification). On February 26, 2004, FDA published a              regulatory agencies, managing
    final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on            enforcement actions and mitigating
    certain human drug and biological products to help reduce                          compliance exposure for companies,
                                                                                       working with Notified Bodies, AR’s
    medication errors in hospitals and other health care settings. The bar
                                                                                       and demonstrates credible
    code is intended to enable health care professionals to use bar code
                                                                                       experience to maximize business
    scanning equipment in conjunction with computerized medication                     performance in the devices arena.
    administration systems to verify that the right drug, in the right dose,           ...more
    is being given to the right patient at the right time. This rule (now
    codified at 21 CFR 201.25 and 610.67) requires that manufacturers
    encode the unique National Drug Code (NDC) number in a linear bar
                                                                                      Suggest a Topic       More Webinars
    code on the product's label.
                                                                                        Your Necessity is our Priority

    Areas Covered in the Session:

       l   Understand how to implement the Unique Device Identification
       l   Identify the uses and benefits of UDIs
       l   Understand the challenges, recommendations and proposed
           conclusions from multiple groups
       l   Review examples of Device Identification management
           scenarios reflecting the benefits
       l   Learn where the use of medical device identification
           encompasses four current main elements

    Click here to register for this webinar

    Who Will Benefit:
 This webinar will provide a general overview and update to
 companies who need to better understand industry's and FDA's
 current overview of Unique Device Identification. The employees who
 will benefit include:

     l   All end-users from appropriate departments who desire or
         require a better understanding and overview of Unique Device
         Identification and current update.
     l   QA and Compliance
     l   Regulatory Affairs and RA Specialists
     l   Marketing
     l   Consultants
     l   Technical Writers and employees who review labeling/tracking

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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