
©bongkarn thanyakij via Canva.com
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:
Areas Covered in the Session :
Who Will Benefit:
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)
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
Create your own event
Turn your passion into a business.
Turn your passion into a business.