Unique Device Identifier (UDI) Implementation - By Compliance Global Inc.

Unique Device Identifier (UDI) Implementation - By Compliance Global Inc.

 

  • Unique Device Identifier (UDI) Implementation

    Live Session for one participant

    Sale Date Ended

    USD 155
    Sold Out

Invite friends

Contact Us

Page Views : 67

About The Event

Overview

 

This webinar on Unique Device Identifier (UDI) requirements will discuss the new rules implemented by FDA. Attendees will get an overview of the new requirement and how to implement.

 

Why Should You Attend

 

FDA registration has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning.

FDA UDI requires understanding of several major steps:

  • Producing compliant device labels, packaging 
  • Uploading the appropriate information into the GUIDID 
  • Updating affected work instructions and/or standard operating 

The UDI regulations include changes: 

  • Part 803 (Medical Device Reporting)
  • Part 806 (Medical Devices, Reports of Corrections and Removals)
  • Part 814 (Pre-market Approval of Medical Devices)
  • Part 820 (Quality System Regulation)
  • Part 821 (Medical Device Tracking Requirements)
  • Part 822 (Post-market Surveillance)

You will learn the UDI elements, where it should be placed (on device, label, labeling and package, and configurations), and the Global Unique Device Identification Database (GUDID) data requirements.

 

Areas Covered in this Webinar

 

  • Introduction to UDI requirements
  • Device classifications
  • Overview of GUDID key concepts (Review of GUDID Modules)
  • The UDI record
  • UDI on labels, packaging designs
  • Submission and 21 CFR 11 requirements

 

Learning Objectives

 

  • Understanding the UDI requirements 
  • What is expected
  • Implementation planning

 

Who Will Benefit

 

  • Regulatory Specialists/Managers
  • Labeling Specialists
  • Quality Specialists/Managers
  • Quality Engineers

Level:

Beginner

For more detail please click on this below link:

https://www.complianceglobal.us/product/700249

Email: referrals@complianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515