Meeting Global Unique Device Identification Requirements


 

Meeting Global Unique Device Identification Requirements: Regulation, compliance seminars 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.


Webinar Takeaway


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


Intertwining Regulatory, Commercial, and Patient-Safety Information


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

Initial Development, Maintenance, and Reuse of Information

Supporting global use-cases

UDI Best Practices


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.


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


Industries who can attend


This 90-minute online course is intended for professionals in the medical device training, Biotechnology,pharmaceutical training. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

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