Unique Device Identification (UDI) Final Rules Overview

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Description:

This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013.

This webinar is further intended to help you effectively implement a unique device identification (UDI) system (UDI system). 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 how to implement the UDI system requirements in a CAC-SI manner.

Areas to be Covered:

Applicable Statute(S), Regulations and Enforcement Authority
Definitions
UDI Development 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
Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
Conclusion

Who will Benefit:

R&D Scientists, Managers, Directors, and VPs
Regulatory Affairs and Compliance Professionals
Clinical Affairs Professionals
Quality Professionals
Consultants
Legal and Compliance Officers
Marketing Professionals
Senior Management
Anyone Interested in the Subject

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance