Meeting Global Unique Device Identification Requirements: Regulation, Compliance, and Best Practices

Michael C Redmond

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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.

Our UDI expert 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 Webinar Takeaways:

·The Evolution of Universal Device Identification Guidelines

o   Impacts on device identification and product data

o   Global development and implementation of UDI requirements

o   Recommended “shared” data obligations

· Intertwining Regulatory, Commercial, and Patient-Safety Information

o   How regulatory complexities affect device manufacturers

o   Ways manufacturers can work with stakeholders to guide and manage information

· Initial Development, Maintenance, and Reuse of Information

o   Supporting global use-cases

· UDI Best Practices

o   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

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Premier price: $ 539 (save 10%)

Recorded video

Recorded video session

Premier price: $ 314 (save 10%)

Speaker: Michael C Redmond, CEO and Lead Consultant, Redmond Worldwide

Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.

Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.

Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.

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