Online Training 2015 - Unique Device Identifier (UDI) Implementation - By Compliance Global Inc
Date2015-11-19
Deadline2015-11-19
VenueOnline Webinar, USA - United States
KeywordsUnique device identification; Implementation planning; Postmarket surveillance
Topics/Call fo Papers
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-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
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-AT-complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
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Last modified: 2015-10-20 20:21:13