Unique Device Identifier (UDI) Rule Implementation
Duration : 75 Minutes
Marie Dorat,
Marie Dorat, CQA,CAA is a QA/RA compliance, GxP Training and International product registration Consultant with 17 years experience, in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies, develop compliant Quality Systems; Read more
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.
Course Objectives:
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
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.
Course Outline:
By the end of this course, participants will have a understanding of:
• Background of UDI Requirements
• Introduction to UDI Program
• What is a UDI?
o Products under UDI
• Review of Compliance Dates
• Exceptions and Alternatives
• Key Roles in UDI Implementation
• The UDI Record
o UDI on Labels, Labeling and Packaging
o Label Maker Software Compliance
o Direct Markings
• Overview of GUDID
o Submission Options
• Brief Review of Software UDI Requirements
o 21 CFR 11 requirements
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs Specialists/Managers
• Labeling specialists
• Quality Specialists/Managers
• Quality engineers
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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