Preparing for a UDI Implementation

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barcode and GUDID elements, a review of the implementation timeline for manufacturers, overview of the FDA Direct Mark Draft Guidance, the planning process for implementation and a discussion on the challenges already faced and lessons learned.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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