UDI Implementation – What is required ?

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

MD2411

Marie Dorat

Marie Dorat, CQA,CAA is a QA/RA compliance, and Training Consultant in the Pharmaceutical/Medical Device & IVD Industry. She is the CEO of IPRF, LLC which specializes in helping established and start-up companies develop and/or update their quality management systems. IPRF also assists companies process the necessary documents for international product distribution.

Ms. Dorat has 14 years experience in quality assurance and regulatory affairs in the Pharmaceutical/Medical Device & IVD industry, including GxP Auditing Quality Management System development, Training, validation and Supplier Management Program development in the US and internationally. She has held a number of senior QA/RA. She has worked for several companies. She has lectured at conferences and on training courses on QA and GXP topics.

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.

She conducts training courses for both public groups and in-house on topics including: International Product Registration project management, Auditing 101, Writing and managing Quality Systems, GCP , Regulatory requirements for Clinical Trials, FDA audit and EU inspections.

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