22 - 23 April, 2020 | Brussels, Belgium

Workshop Day

9:00 am - 1:00 pm 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
Dawn Fowler, Director, UDI/Master Data Management at Masimo

Dawn Fowler

Director, UDI/Master Data Management
Masimo

9:00 am - 1:00 pm WORKSHOP A2 - What Comes Next? Meeting Commercial UDI Requirements and Preparing for Emerging UDI Regulations

Who’s it for? Open to all levels. Designed for participants that have already mastered the UDI basics and/or are meeting the existing FDA UDI regulations.

Required/Prerequisite Knowledge: Basic understanding of UDI

What do I need to bring? Knowledge of your company’s strategy for meeting commercial UDI Requirements and emerging UDI regulations.

Introduction:
Many device manufacturers are successfully moving towards complying with FDA UDI regulations and are on their way to complying with EU MDR/IVDR UDI requirements. In addition, there are several commercial UDI requests/requirements that need to be considered.
There are also several other countries that are moving UDI regulations. With the recognition of emerging UDI regulations and new market requirements, UDI is no longer a project but a long term process.

Session Objective(s):
This session will focus on commercial UDI requirements. It will include the expectations on labeling, associated data, and where applicable, commercial expectations. It will also highlight the emerging market requirements. 

The session will also include lessons learned from Healthcare Providers during the initial FDA UDI implementation efforts.

What Will be Covered?
  • NHS Scan4Safety overview
  • AHRMM UDI Learning Community
  • Commercial requirements that exceed or differ from regulator requirements
  • Emerging UDI regulations
  • Implementation lessons learned to date
Dennis Black, UDI Program Director, Global Regulatory Operations at BD

Dennis Black

UDI Program Director, Global Regulatory Operations
BD

1:00 pm - 2:00 pm Networking Lunch Break

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
Dawn Fowler, Director, UDI/Master Data Management at Masimo

Dawn Fowler

Director, UDI/Master Data Management
Masimo

Dennis Black, UDI Program Director, Global Regulatory Operations at BD

Dennis Black

UDI Program Director, Global Regulatory Operations
BD