Cybersecurity Exploitation Recovery for Medical Device Software


Instructor: Casper Uldriks
Product ID: 705729

  • Duration: 75 Min
This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.
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Why Should You Attend:

Cybersecurity technology and exploitations evolve rapidly. A static cybersecurity program leaves a software program more vulnerable with each passing day as hackers develop new malware adaptations. Cyber attacks constantly evolve in their impact and deviousness of deployment. The FDA expects you to apply the Quality System regulation (QSR) Corrective and Preventive Action (CAPA) as an established and implemented cybersecurity recovery program and also FDA requires that a software developer, whether for a software based device or for standalone software, address cybersecurity before the device may be marketed. But the cybersecurity problems manifest themselves after premarket authorization. FDA provides little guidance on how to manage a cybersecurity recovery program once you are on the market and have been hit.

What should your cybersecurity recovery program include? You are left with an answer of, "You figure it out".

In this webinar Fundamental cybersecurity program concepts will be identified so attendees have to customize them for their particular needs and implement a program that includes training needs, which is something that can be verified during an FDA inspection. A firm's quality audit division will be provided some initial issues that need to be considered to develop their QA cybersecurity program and how to evaluate adequacy of the programs based on specific factors.

Areas Covered in the Webinar:

  • Initial steps to build a cybersecurity recovery program
  • Basic components of a cybersecurity CAPA Program
  • Human resources requirements
  • Cyber attack recovery components
  • Cybersecurity program checklist

Who Will Benefit:

  • Software engineers, developers and information technology managers
  • Third party software servicers
  • In-house biomedical departments at healthcare institutions
  • Regulatory Affairs Managers
  • Healthcare institution risk managers
  • Product liability counsel
  • Complaint investigation teams
  • Quality assurance directors
Instructor Profile:
Casper Uldriks

Casper Uldriks
Former Associate Center Director, CDRH

Casper Uldriks, through his firm Encore Insight LLC, brings over 32 years of experience with the FDA. He specialized in 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. His comments are candid, straightforward and of practical value. Mr. Uldriks understands how FDA thinks, how it operates, and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. His professional credentials include: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

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