Implementing a unique device identification system
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Implementing a Unique Device Identification System PowerPoint PPT Presentation


This webinar will discuss the regulatory and compliance requirements to implement a system for Unique Device Identification (UDI) including final rules, compliance dates and requirements. The speaker will walk you through the requirements including, but not limited to, what to consider when implementing a UDI system in a proactive, streamlined manner.This seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

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Implementing a Unique Device Identification System

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Implementing a unique device identification system

Implementing a Unique Device Identification System

Speaker: David Lim| Date: 18th May 2016 2016 2016 | 10:00 AM PST | 01:00 PM EST

Contact Us : Email: [email protected] | Tel: +1-248-233-2049


Description

This webinar will discuss the regulatory and compliance requirements to implement a system for Unique Device Identification (UDI) including final rules, compliance dates and requirements. The speaker will walk you through the requirements including, but not limited to, what to consider when implementing a UDI system in a proactive, streamlined manner.

This seminar is intended to help you effectively implement a unique device identification (UDI) system (UDI system) based on the final rules issued on September 20, 2013 and published in federal register on September 24, 2013. This final rule is effective 90 days after date of publication in the federal register. Specifically, new changes in the final rules will be discussed, contributing to saving an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.

Description:


Areas covered in the session

  • Applicable Statute, Regulations and Enforcement Authority

  • Definitions

  • UDI Development History

  • UDI Final Rules: Technical Requirements and Changes Made

  • Requirements for a Unique Device Identifier

  • UDI Rules: Applicability

  • UDI Rules: Exceptions and Alternatives

  • Devices Labeled Prior to Compliance Dates

  • Class I Devices: cGMPs Exempted

Areas Covered in the Session:


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

Who will benefit:


Instructor profile

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.  

Instructor Profile :


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