Description:
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 Objective
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, 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
- 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
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Target Audience
This webinar will benefit the professionals working in medical device industries.
- Regulatory Specialists/Managers
- Labeling specialists
- Quality Specialists/Managers
- Quality engineers
Speaker: Marie Dorat,
Marie Dorat, CQA,CAA is a QA/RA compliance, Training and International product registration Consultant in the Pharmaceutical/Medical Device & IVD Industry She also is the CEO of IPRF, LLC which specializes in helping established and start-up companies process the necessary documents for international product distribution. Ms. Dorat has 12 years’ experience in quality assurance and regulatory affairs in the harmaceutical/Medical Device & IVD industry, including auditing clinical trials, manufacturers, and distributors in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies including Pfizer, and Alere She has lectured at conferences and on training courses on QA and GXP issues. She has also worked directly with various companies in the Pharmaceutical & Medical Device industry, assisting with international new product registrations as well as rebranding products after an acquisition or merger. She has developed a process to reduce time to market for most companies by several months.
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To register/enquire, please contact:
www.compliance.world
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