Update on Unique Device Identifier for Device Manufacturers - Webinar by GlobalCompliancePanel

Website http://bit.ly/19W5Bew | Edit Freely

Category Webinar, Health, Medical, Pharma, Clinical

Deadline: October 01, 2013 | Date: October 01, 2013

Venue/Country: USA, U.S.A

Updated: 2013-09-16 13:20:09 (GMT+9)

Call For Papers - CFP

The reports further indicated that many issues have to be addressed prior to successful implementation of UDI for devices, including determining the technology needed to utilize UDI effectively, identifying the data needed for patient safety; development, maintenance, and validation of a central data repository; and harmonizing UDIs for the international marketplace. FDA is reconsidering whether some form of unique device identification (UDI) is warranted for medical devices, given the potential of UDI to help reduce medical errors, facilitate recalls, and other issues identified from above but also improve inventory control, improve reimbursement, and reduce product counterfeiting. Once your device is approved, ongoing regulatory requirements fall largely into two categories: labeling and tracking. How does UDI fall into this category?

Why should you attend:

Understand how the use of a unique device identification (UDI) system may improve patient safety, e.g., by reducing medical errors, facilitating device recalls, and improving medical device adverse event reporting. Understand some of the issues associated with the use of various automatic identification technologies (e.g., bar code, radiofrequency identification). On February 26, 2004, FDA published a final rule (the ``bar code rule'') (69 FR 9120 ) requiring bar codes on certain human drug and biological products to help reduce medication errors in hospitals and other health care settings. The bar code is intended to enable health care professionals to use bar code scanning equipment in conjunction with computerized medication administration systems to verify that the right drug, in the right dose, 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 code on the product's label. The bar code rule, however, does not apply to medical devices. In the bar code rule, FDA stated that, unlike drugs, medical devices do not have a standardized, unique identifying system comparable to the NDC number, and that the absence of such a system complicates efforts to put bar codes on medical devices for purposes of preventing medical errors. Since the issuance of the final bar code rule, various entities, including members of Congress and a consortium of hospital groups and manufacturers, have asked that the Agency revisit the issue of bar coding medical devices to improve patient safety; improve quality of care; and encourage cost effectiveness, e.g., of health care by improving delivery and supply chain efficiency.

Areas Covered in the Session:

Understand how to implement the Unique Device Identification

Identify the uses and benefits of UDIs

Understand the challenges, recommendations and proposed conclusions from multiple groups

Review examples of Device Identification management scenarios reflecting the benefits

Learn where the use of medical device identification encompasses four current main elements

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:

All end-users from appropriate departments who desire or require a better understanding and overview of Unique Device Identification and current update.

QA and Compliance

Regulatory Affairs and RA Specialists

Marketing

Consultants

Technical Writers and employees who review labeling/tracking info

David R. Dills, Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/19W5Bew