Requirements of the US Food and Drug Administration's (FDA) UDI ruling has significantly impacted the healthcare industry. Failure to provide accurate information about each of your products will make them unfit for sale in the US - similar legislation is imminent for the EU and other territories. The FDA mandate for Class III devices took effect in September 2014 with deadlines for Class II and I devices following in subsequent years.
The provision of accurate product data is fundamental to helping maintain healthcare supply chain integrity. In healthcare, good buying decisions saves lives. Unique Device Identification (UDI) is imperative to this cause, permitting an accurate record of a device's use for inclusion in patient healthcare records. UDI's enable track and trace, allow devices to be easily identified and recalled; reduce medical errors and improve supply chain efficiency.
While much focus has been given to UDI label production, little has been given to the product data management process and the requirements to register this information into the GUDID (Global UDI database).
This webinar will discuss and incorporate the following:
- How using GS1 Standards will help manufacturers streamline the process for product data aggregation and publish to the GUDID using the Global Data Synchronization Network (GDSN).
- Will discuss a case study of the findings of a leading US medical device manufacturer which has recently undertaken this journey to meet the Class III device deadline.
- We will also provide you with valuable insight on how to prepare for upcoming Class II device requirements, as well as provide an update on what to expect in Europe over the coming months.
Eugene King,
Senior GDSN Consultant
Eugene King has worked at LANSA for 15 years, consulting on various integration and workflow automation projects for companies adopting standards, meeting regulatory requirements and seeking to improve supply chain efficiency. Eugene is also Product Manager for LANSA’s data quality solutions, and GDSN accredited with GS1 UK, which is a validation of knowledge to provide solutions based upon GS1 standards.
Jenny Gough,
Process Development Manager/GS1 & UDI Specialist at Mölnlycke Health Care
Mr. Johansson has over 40 years' experience in the pharmaceutical industry and currently serves as the CEO/owner of BiQ Pharms and AQPS Academy of Quality in Pharm Science. Mr. Johansson also worked at Biotechvalley AB as the CEO and a senior consultant, quality director at Pfizer, Fresenius Kabi, Pharmacia, and the head of analytical laboratory at Astra. Mr. Johansson received his Master of Science in chemistry from KTH Royal Institute of Technologhy in 1980 and his MBA from Uppsala University in 2000.
Julien Meissonnier,
Director of R&D, Catalent Pharma Solutions
Jenny is a GS1 & UDI specialist at Mölnlycke Health Care, a world-leading provider of single-use surgical and wound care products. Jenny works on implementing GS1 Standards for Medical Devices and Pharmaceutical products. She has not only implemented GS1 standards for product marking, but is also heavily involved in projects for which GS1 would have an impact, eg E-Catalogue, Traceability, etc.
Jenny has been working with GS1 standards since 1996. Previous to Mölnlycke Jenny held positions within FMCG companies working within the retail sector. In 2004 she became a member of the Bar Code Standards Group at GS1 UK. Jenny also holds positions as the Co-Chair of the both GS1 UK Health Care User Group and Vice Chair of the Eucomed UDISC Group.
- Understand your responsibilities to comply with worldwide UDI regulations
- Discover how using the GS1 system of standards can help you achieve compliance
- Learn valuable tips and techniques regarding data quality to make the journey easier and quicker
- Gain insight into how product data management processes deliver value beyond compliance
- Regulations
- QA
- Quality Engineer
- Compliance
- Logistics
- Validation professionals
- Product Managers
- Project Managers
- IS/IT Managers
- UDI Program Manager
- Operations
- Supply Chain
- Regulatory Affairs
- Regulatory Manager/Specialist
