One Day Virtual Seminar on Implementing UDI (Unique Device Identification) - Plan Now for Success: March 16, 2021 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Implementing UDI (Unique Device Identification) - Plan Now for Success" conference has been added to ResearchAndMarkets.com's offering.

The one-day virtual seminar 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 virtual seminar 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 seminar helps you identify the requirements for the UDI elements:

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

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

Who Should Attend:

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

Agenda:

Day 01 (12:00 PM to 6:00 PM EDT)

12:00 PM - 1:15 PM - 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

1:15 PM - 1:30 PM - Break

1:30 PM - 3:00 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

3:00 PM - 4:30 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

4:30 PM - 6:00 PM - Updating the QMS

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

For more information about this conference visit https://www.researchandmarkets.com/r/2scau1