22 - 23 April, 2020 | Brussels, Belgium
Dawn Fowler, Director, UDI/Master Data Management at Masimo

Dawn Fowler


Director, UDI/Master Data Management
Masimo

Check out the incredible speaker line-up to see who will be joining Dawn.

Download The Latest Agenda

Workshop Day

Tuesday, April 23rd, 2019


9:00 AM WORKSHOP A1 - UDI Boot Camp: The Fundamentals of UDI Compliance and Implementation

Who’s it for?  Those new to UDI or looking for a refresher

Required/Prerequisite Knowledge: None

What do I need to bring? Nothing

Introduction:
This workshop will cover UDI basics including tactical information needed to prepare your organisation for global UDI compliance.

Session Objective(s):
To leave with clear understanding of global UDI requirements to aid in development and implementation of a sustainable UDI programme.

What Will be Covered?
  • What UDI is and what compels compliance
  • Barcode basics - understanding of systems, carrier types, validation and verification
  • Direct marking
  • Database (GUDID, GDSN/NHS) basics
  • Designing for readiness
  • UDI program implementation case studies

Key Take-Homes:
  • UDI basic rules and requirements
  • Understanding of barcodes – data breakdown, types, placement
  • Understanding of FDA and EU MDR requirements for UDI
  • Knowledge surrounding UDI databases
  • Strategy, planning and implementation of a UDI program

2:00 PM WORKSHOP B - Master Data Management and Beyond

Who’s it for? Open to all levels. Required/Prerequisite Knowledge: Basic understanding and/or previous experience with UDI

What do I need to bring? Nothing

Introduction:
Although many manufacturers have finished, or are finishing, compliance with the US FDA regulations, there are new UDI requirements developing internationally. With global recognition and development of international requirements, UDI is no longer a single project, but a long-term process.

Session Objective(s):
This session will focus on UDI/Master Data Management processes, systems and standardisation to gain global UDI compliance. It is targeted towards those with prior UDI experience, or beginners continuing from Workshop A1.

What Will be Covered?
  • Development of governance and strategy building on “Source of Truth”
  • Implementation of an Internal/External centralised data source
  • Integration strategies for new regulatory data mandates
  • Lessons learned to date

Key Take-Homes
  • Understanding of new global UDI & Master Data requirements
  • Current understanding of FDA and EU MDR requirements for UDI
  • Leveraging UDI data internally

Conference Day 2

Thursday, April 25th, 2019