Regulators, Risks & Readiness: Cybersecurity meets Compliance (11034)

Cybersecurity and compliance are no longer separate issues, they are converging in powerful ways within the Life Sciences industry. In this session, James R. Francum will connect regulatory requirements such as FDA 21 CFR Part 11 and EU Annex 11 with the broader ISO 27000 cybersecurity framework. He will explore how Annex 11 and cybersecurity come together, and how inspectors are now evaluating information security as a critical part of compliance. Drawing on the FDA’s Compliance Program and global best practices, James will highlight the compliance aspects of cybersecurity that organizations must address to remain inspection-ready. The session will also touch on one of the hottest topics in the field today: cybersecurity risks in AI/ML development and their regulatory impact.

Key Takeaways
After attending this webinar, you will:

• Understand how FDA 21 CFR Part 11, EU Annex 11, and ISO 27000 connect, and where compliance meets cybersecurity
• Recognize how Annex 11 already addresses information security and what that means for your organization
• See how the FDA Compliance Program drives inspector focus on cybersecurity during reviews
• Identify the compliance aspects of cybersecurity that are critical to staying inspection-ready
• Gain awareness of AI/ML development risks and why regulators treat them as a compliance concern

Duration: approx. 90 Minutes
Presentation Language: English 
Referent:  James R. Francum

If you are unable to attend on the day of the live webinar, please let us know when you register. We offer you the option of streaming the webinar individually afterwards.

Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant

Especially for groups - Your benefits at a glance

• Attractive special prices or discounts for entire teams or small groups.
• On request, we offer customised inhouse-packages that are perfectly tailored to the needs of your department or company.
• Book Streaming+ option: Take advantage of our flexible Streaming+ format, which also allows you to have an interactive live Q&A session with the speaker to clarify your questions directly with the expert.

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