Meeting Global Unique Device Identification Requirements – Webinar Recording/Transcript
Meeting Global Unique Device Identification Requirements: Regulation, Compliance and Best Practices
Requirements around Unique Device Identification (UDI) are evolving. Despite efforts by the Global Harmonization Task Force and International Medical Device Regulator Forum to integrate global expectations, national guidelines have continued to develop in differing ways.
Even now, when the deadline for final implementation of Class I products is quickly approaching in the United States and UDI timelines in the EU remain unchanged due to COVID-19, regulatory bodies in other countries are starting to implement their own new programs.
For a company working to manufacture and deliver products around the world, meeting all these needs is complicated.
If you’re searching for the best way to fulfill the competing needs of various identification requirements or hoping to find the most efficient way to appropriately identify your product in different global markets, this webinar has your answers.
UDI expert Jay Crowley will share ways to manage multiple regulatory bodies, best practices around establishing and maintaining robust and effective global UDI processes, possible responses to distinct local UDI concerns and how to submit identification product data to various stakeholders.
Key Presentation Takeaways:
- The Evolution of Universal Device Identification Guidelines
- Impacts on device identification and product data
- Global development and implementation of UDI requirements
- Recommended “shared” data obligations
- How regulatory complexities affect device manufacturers
- Ways manufacturers can work with stakeholders to guide and manage information
- National and local regulatory concerns: counterfeits, traceability, cost controls
- Supporting global use-cases
- EU UDI requirements, including EUDAMDED expectations
Finding the best way to meet shifting global identification obligations is a complicated balancing act. Learn how to navigate the process and discover the most effective, practical solutions to your international UDI concerns. Join us by registering today.
Meet Your Presenter:
Jay Crowley, vice president of Unique Device Identification Solutions and Services at USDM Life Sciences, is an expert in the business process, technology, and compliance solutions for the regulated life science industry. Most recently, Mr. Crowley was the senior advisor for patient safety at the FDA’s Center for Devices and Radiological Health. There, he developed the framework of and authored key requirements for the FDA’s UDI system. During his nearly 27 years with the agency, Crowley worked with design control regulations to reduce the chance of human errors with medical devices, patient safety, and adverse event reporting. He also worked in the Office of the Commissioner and the Office of Compliance at the FDA.
Who Will Benefit:
- Companies globally commercializing medical devices
- Quality assurance staff
- Regulatory affairs staff
- Supply chain management staff
- Device labeling staff
- IT staff
- Product development and support staff