UNDERFDA’S JULY PROPOSED RULE,AND PURSUANT TO 2013 - Live Web Seminar on FDA Unique Device Identifier Requirements and Issues ? What is Industry Facing? By Jonathan M. Weinrieb

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Category Medical Device

Deadline: April 02, 2013 | Date: April 03, 2013

Venue/Country: Houston, U.S.A

Updated: 2013-02-15 17:26:50 (GMT+9)

Call For Papers - CFP

UnderFDA’s July 2012proposed rule,and pursuant to the statutory requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the labels of most medical devices and medical device packages will be required to include a Unique Device Identifier (UDI).

FDA’sproposal allowing for UDI implementation via multiple standards and data formats could render it difficult for supply chain partners to effectively use the UDI on a daily basis.

Description of the topic

During this webinar, participants will be provided with an understanding of: the overall legal framework under which FDA proposes regulating the application of UDI tomedical device labels and packagingand the key legal and policy concepts under which the agency intends to proceed.

The workshop will provide participants with an explanation of the proposed standards for UDI implementation and the parameters within which companies can lawfully operate, including certain limited exemptions for particular categories of devices.

Finally, the workshop will discuss potential operational roadblocks to implementation that certain companies may face.

Areas Covered In the Seminar

FDA’s proposed regulation of UDI generally.

Potentially applicable standards that may be used by manufacturers implementing UDI and their effect on entities down the supply chain.

Principles for assuring compliance with FDA requirements and expectations.

Potential impact on industry if FDA’s Proposed Rule is made final without modification.

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Who will benefit

Representatives of manufacturers, distributors, retailers, and end-users ofmedical devices, including in-house counsel, outside FDA counsel, regulatory affairs personnel,and regulatory consultants.

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

About Speaker

Jon Weinrieb has been practicing food and drug law since 1999 when he began to represent pharmaceutical manufacturers in complex mass tort litigation. His current practice focuses on healthcare-related privacy issues arising under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Health Information Technology for Economic and Clinical Health (HITECH) Act, and similar state laws and regulations. His clients include individual physician and non-physician healthcare professionals, vendors of healthcare information and their HIPAA Business Associates, and myriad other entities regulated by the HIPAA Privacy Rule and Security Rule.

Mr. Weinrieb also represents pharmaceutical and food manufacturers and wholesale distributors regulated by FDA, USDA and a variety of state regulatory agencies. He advises clients on a range of topics including the regulatory status of ingredients, manufacturer and wholesaler licensing and registration requirements and food and drug advertising and labeling issues. He also counsels trade associations on Antitrust and First Amendment considerations specific to the food and drug industry.

In addition to maintaining an active healthcare, food, and drug law-based practice, Mr. Weinrieb also has broad experience in the areas of Products Liability and Insurance Coverage litigation. He successfully represented a major pharmaceutical company in a series of complex products liability matters that were ultimately dismissed in favor of his client on evidentiary (Daubert) grounds.

Speaker : Jonathan M. Weinrieb

Product ID : F62219

Schedule Date :

Wednesday, April 03, 2013

duration : 01:00 to 02:00 PM EST

https://compliance2go.com/index.php?option=com_training&speakerkey=57&productKey=229