UDI Implementation – What is required ?

Date	Jul 11, 2018
Time	03:00 PM EDT
Cost	$13420.00
Online

The US FDA has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning.
UDI implementation 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, the New Requirements and 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 the Session :

• Introduction to UDI requirements
• Device Classifications
• Overview of GUDID key concepts (Review of GUDID Modules)
• The UDI Record
• UDI on Labels, Labeling and Packaging
• Submission and 21 CFR 11 requirements

Who Will Benefit:

• Regulatory Affairs Departments
• Quality Assurance Departments
• Labeling Departments
• Quality Specialists
• Quality Engineers