How The GUDID Was it?
Implementing and achieving UDI compliance – have the benefits of UDI outweighed the pain?
For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. In the last couple of years the fruition of the FDA’s UDI (Unique Device Identification) requirements - a single global regulation for uniquely pinpointing medical devices in the supply chain - has meant that all medical device companies trading in and to the USA must comply.
As part of the directive, organizations must submit product information in a computer-readable structured labeling format to the GUDID (Global Unique Device Identification Database) - a publicly searchable database. For many, the journey has not been a simple path and many organizations have had to make huge changes to their internal and labeling processes to stay compliant.
In a 2015 survey, 74% of manufacturers stated that the key driver to make changes to their labeling process was ensuring regulatory compliance, yet 62% would find it difficult to assess the impact of making changes to their system. Time-lining when and how to make essential changes to stay compliant with regulations while keeping the production line rolling is a tough balancing act, and this webinar looks at how well companies have managed the change.
Key Learning Objectives:
- Learn how the UDI requirements have affected labeling and labeling processes
- Discover what the main challenges were, and how manufacturers are continuously working to meet them
- Ascertain if you’re ready for an FDA inspection which includes UDI activities
- Gain a greater understanding of making your labelling processes more efficient, compliant and risk free
Kevin Grygiel, VP Strategic Accounts & Partner Ecosystem, PRISYM ID
Has over 15 years' experience in software development and implementation helping to deliver complex and personalized business solutions to Life Sciences customers.
Kevin has a proven ability to focus, align and build effective teams with an uncompromising regard for customer impact. He also has the ability to conceptualize, develop and deliver innovative solutions and services that address and resolving enterprise-wide business needs resulting in a high degree of customer loyalty and retention.
Gary Saner, Sr. Manager of Information Solutions, Reed Tech
Gary is a subject matter expert on UDI and other structured content submissions to regulatory agencies. Gary has over a decade of experience in the Life Sciences industry and has worked for more than 30 years in the areas of software development, process management and data conversion.
Neil Piper, Senior Manager AIDC, GS1
Neil is an Auto ID expert and business consultant, with over 25 years’ experience working predominantly in the retail and healthcare sectors.
He was part of the original Department of Health and Social Care working group that advocated the use of GS1 standards in the NHS in England back in 2007. And since then, has worked closely with numerous NHS trusts, Connecting for Health (Information Standards Board), NHS Digital (Data Standards Assurance Service), NHS England, and Health and Social Care in Northern Ireland.
Neil has also worked closely with the Commercial Medicines Department and supported their submission to the EU for the Falsified Medicines Directive, and co-wrote the ISB 1077 Patient Identification, and ISB 0108 AIDC, NHS standards.