Industry: Healthcare

Regulation, Compliance, and Best Practices Webinar July 29, 2020

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Searching for the best way to fulfill the competing needs of various device identification requirements? Looking for the most efficient way to appropriately identify a product in different global markets?

The task of meeting unique device identification (UDI) guidelines can be complicated. Requirements around the world are evolving and despite efforts by the Global Harmonization Task Force and International Medical Device Regulator Forum to integrate global expectations, they are evolving in different ways in different places.

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.

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 EUDAMED 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 international UDI concerns.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

Meeting Global Unique Device Identification Requirements:

Regulation, Compliance, and Best Practices

An FDAnews Webinar

Wednesday, July 29, 2020, 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/udirequirements

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/udirequirements

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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