Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Join us for a webinar on October 01 for a discussion of the webinar
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.
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, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Kelly Thomas
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.