Implementing UDI (Unique Device Identification) – Plan Now for Success: One-day In-person Seminar

By: Lena Cordie Bancroft, President, Qualitas Professional Services, LLC
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Course Description:

The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter.

The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID

The workshop helps you identify the requirements for the UDI elements:

  • Procedure changes
  • Label UDI
  • Package UDI
  • Direct marking UDI
  • Date format
  • Entry into GUDID

The workshop helps you implement the changes, update your procedures, and determine when you need to revalidate databases.

Who will benefit:

  • Regulatory Managers
  • Design Engineers
  • Labeling Specialists
  • Project Managers
  • Quality Managers
  • Quality Engineers
  • Executive management
  • R&D staff
  • Strategic planning staff

Topic Background:

All medical devices marketed in the US, with limited exceptions, must have unique device identification. The first phase is the revised regulations with an effective date of Dec. 23, 2013.

The subsequent phases depend on device attributes such as regulatory class, intended use (life sustaining or life supporting), reusable & reprocessed, etc. FDA-CDRH published a simple table, by compliance date. However, device manufacturers need a more refined analysis to classify their products and determine the compliance dates.

For each compliance date, depending on the device characteristics, the manufacturer puts the UDI on the label, changes the label’s date format, includes the UDI on packaging configurations, and enters information into the FDA-CDRH database called the GUDID. In some case, the manufacturer puts the UDI on the device itself.

By September 24, 2016, all manufacturers of Class 2 devices must implement UDI (label, package, and GUDID). You need to understand the regulation and develop your plans now or you won’t be ready. There are a lot of details in the implementation and you will need time to handle all of them.

You need to plan your implementation. You have only two choices.

  • You could assign somebody as the subject matter expert. This means reading and understanding the 160 page final rule as well as the ever changing guidance documents
  • You could send your implementation team to this workshop designed to clarify the requirements and provide hand-on practice in the implementation

Course Outline

Day One (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  • 9:00 AM – 10:15 AM - Overview of the UDI Rule
    • Distinguishing among Identification, Tracking, and Tracing
    • The elements of the system: UDI and GUDID
    • Determining applicability
    • Determining compliance dates
    • UDI locations: device, label, and package
    • The GUDID and its data elements
    • The required organizational structure
    • Loading the data into GUDID
    • Change control (when you need a new DI)
    • Exercise – Participants review cases to determine if a change requires a new device identifier
  • 10:15 AM – 10:30 AM - Morning Break
  • 10:30 AM – 12:00 PM - Device, Label, & Package UDI
    • UDI = DI + PIs
    • Compliance Dates
    • Direct Marking
    • Device Label
    • Package Configurations
    • Accredited Issuing Agencies
    • UDI Specification by Issuing Agency
    • Exercise – Participants review cases to determine the compliance date
    • Exercise – Participants apply the packaging configuration rules
  • 12:00 PM – 1:00 PM - Lunch
  • 1:00 PM – 2:30 PM - Populating the GUDID
    • The GUDID Data Elements The organizational structure for GUDID maintenance The technical methods for GUDID data loading Exercise – Participants determine some GUDID data for example cases Exercise – Participants develop GUDID data for one of their own devices
  • 2:30 PM – 2:45 PM - Afternoon Break
  • 2:45 PM – 4:30 PM - Updating the QMS
    • Quality System Regulation
    • Medical Device Reports
    • Corrections and Removals
    • Record Retention
    • FDA Inspections
    • Related Issues
      • 510(k)
      • eMDR

Meet Your Instructor

Lena Cordie Bancroft
Lena Cordie Bancroft
President, Qualitas Professional Services, LLC

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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