WCG FDAnews Announces: Medical Device Cybersecurity Webinar on March 8, 2023

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Cybersecurity-related inspection practices are intensifying for medical device manufacturers who now need to be prepared to defend their cybersecurity strategy during facility inspections.

Eric Henry, a senior quality systems and compliance adviser in the FDA and Life Sciences practice of the law firm King & Spalding, and Christopher Gates, director of product security at Velentium, will explain the FDA’s cybersecurity expectations, design controls, the importance of threat modeling and vulnerability assessment as a component of cybersecurity defense, and how manufacturers may best interact with FDA investigators and other auditors not familiar with cybersecurity basics.

Webinar takeaways:

  • How cybersecurity activities fit into traditional design controls and safety risk management for medical devices when integrating into quality management systems
  • What the FDA is already addressing in inspections from its new draft cybersecurity guidance
  • How to address postmarket cybersecurity activities during inspections
  • Common themes in the current library of cybersecurity regulations, standards, and guidance
  • Understand new cybersecurity regulations, standards, guidance and/or white papers in progress that will have a significant impact on the medical device industry beyond the FDA’s draft guidance
  • Learn about common cybersecurity deficiencies found during FDA inspections and notified body audits, and how to ensure these are not found

Webinar Details
Medical Device Cybersecurity:
The Regulatory Landscape and How to Defend Your Practices During an Inspection
An FDAnews Webinar
Wednesday, March 8, 2023, 1:30 p.m.-3:00 p.m. EST


Easy Ways to Order:
Online: https://wcg.swoogo.com/medical-device-cybersecurity-regulatory-landscape
By phone: 888.838.5578 or 703.538.7600

About WCG FDAnews:
WCG 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 WCG FDAnews' newsletters, books, databases, webinars and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations. Learn more at fdanews.com.

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Michelle Butler
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