Implementing a Unique Device Identification (UDI) System - Issued on September 24, 2013

Website https://www.compliance2go.com/product/?pid=CP2014-288 | Edit Freely

Category Biotechnology , Healthcare , Medical Device , Pharmaceutical

Deadline: April 23, 2014 | Date: April 23, 2014

Venue/Country: houston, U.S.A

Updated: 2014-02-14 15:38:34 (GMT+9)

Call For Papers - CFP

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

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

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