Cybersecurity: Coping with FDA Corrective & Preventive Actions

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Apr 17, 2018
60 minutes
Product Description

How to Prevent, Minimize, and Cope with Cyberattacks

Cybersecurity risks are a reality for all businesses today—and those in the medical field are no exception. Particularly, with increased use of wireless technology and software in medical devices today, curbing cybersecurity threats must be a chief goal for production teams. While cyber threats cannot be eliminated, nor is federal interest in cybersecurity going to diminish, your company can take critical steps now to prevent being tomorrow’s news headline.

Casper Uldriks has more than three decades of experience with the Food and Drug Administration’s (FDA) medical device programs: He knows how the agency thinks and operates, and where it is headed. Join him in this fast-paced webinar as he walks you through specific steps to meeting basic cybersecurity threats—before an attack, during one, and in the recovery phase. He will explain why you must commit financially to supporting a quality assurance plan—and a Total Product Life Cycle plan using quality systems and FDA-recognized voluntary standards.

Uldircks will also walk you through the pros and cons of signing up for an FDA program that allows your company to avoid submitting required reports of action recalls due to cybersecurity problems if you share other relevant information.

After attending this audio event, you will know how to: deter a cyberattack, reduce your exposure in the event of an attack, recover from an attack, and manage in-house and public disclosure statements. Plus, you’ll understand what it means to opt in to the alternate cybersecurity recall correction.

Session Highlights

Here is a taste of what you will uncover:

  • How to reduce the impact of a cybersecurity attack
  • Steps to take to recover from cybersecurity intrusions
  • Steps to take to reduce the likelihood of new cybersecurity intrusions
  • How to manage in-house and public disclosure statements
  • What it means to opt in to the alternate cybersecurity recall correction program

Who Should Attend

  • Regulatory affairs directors
  • Software designers
  • Specification designers
  • Production managers
  • Quality assurance directors
  • Public relations managers
  • In-house legal counsel

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Casper E. Uldriks

 Casper (Cap) Uldriks brings over 32 years of experience from the FDA.  He specializes in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He...   More Info
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