UDI: It Won't Wait Until You Are Ready

precon

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 10:15 a.m.

Part A – 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 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Device, Label, & Package UDI

  • UDI = DI + PI
  • 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 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:30 p.m.

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 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:00 p.m.

Updating the QMS

  • Quality System Regulation
  • Medical Device Reports
  • Corrections and Removals
  • Record Retention
  • FDA Inspections
  • Related Issues
    • 510(k)
    • eMDR

 

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