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.

Register before September 5, 2015 and get the below materials for FREE!!!

  • Slides from the PowerPoint presentations
  • Exercise worksheets and answer keys
  • Updated versions of all the FDA-CDRH parts affected by the UDI rule (Parts 801, 803, 806, 814, 820, 821, 822, and 830) formatted to make them easier to read
  • An analysis of the MDR regulation covering both UDI and eMRD requirements
  • A checklist to help implement the regulatory changes
  • An analysis of Compliance Dates based on the characteristics of your device
  • A label and package implementation checklist
  • A package configuration worksheet
  • An Excel worksheet that simulates GUDID
  • A copy of the UDI final rule
  • Copies of the current CDRH guidance documents on UDI and other supporting material

Who will Benefit:

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

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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

Dan O'Leary
President of Ombu Enterprises, LLC

Dan O'Leary is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and certified by APICS in Resource Management.

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