VIEWS: 32 PAGES: 2 CATEGORY: Medicine POSTED ON: 4/27/2012
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.
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 info 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. 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"Update on Unique Device Identifier for Device Manufacturers"