ComplianceOnline

Preparing for a UDI Implementation

Instructor: Lena Cordie
Product ID: 704579
  • Duration: 90 Min
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This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.

Why Should You Attend:

This webinar will provide an overview of the FDA’s Unique Device Identification regulation requirements, including a breakdown of the UDI barcode and GUDID elements, a review of the implementation timeline for manufacturers, overview of the FDA Direct Mark Draft Guidance, the planning process for implementation and a discussion on the challenges already faced and lessons learned. If you are already familiar with UDI, this session will be a review for you, and serve as an interactive platform to voice your comments and understand the industry perspective. If you are not familiar with UDI, this session will answer many of the questions you didn’t know you had without overwhelming you.

Learning Objectives:

  • Understand the requirements of the FDA UDI regulation
  • Understand the labeling requirements of the UDI regulation
  • Learn what data elements make up a UDI compliant barcode
  • How to verify compliance to standards
  • Understand the GUDID data attributes and submission process and be able to begin compiling data

Areas Covered in the Webinar:

  • Overview of UDI Regulation
  • Labeling Changes
  • GUDID Data Elements
  • GUDID Submission Option
  • Incorporating UDI into the Quality System
  • Verification
  • UDI Planning Checklist

Who Will Benefit:

  • Quality associates and managers
  • Regulatory associates and managers
  • Marketing
  • Operations personnel
  • Labeling engineers

Instructor Profile:

Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.

As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global medical device companies.

She is an active member of AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the terminology committee; ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups; and RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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