FDA's Regulatory Management of Your Cybersecurity Threats

Duration: 60 Minutes
FDA expects firms to develop and implement a cybersecurity management program to reduce the impact of malware intrusion. That poses a big challenge because cybersecurity technology constantly evolves into more sophisticated methods, devastating malware packages and increased stealth in avoiding detection and identification. If your cybersecurity program is relatively static, it turns your software design into a sitting duck. Vigilance plays a key role in cybersecurity management. FDA requires software developers to address cybersecurity issues before and after the software-based devices are marketed.
Cybersecurity Management Program
Instructor: Casper E Uldriks
Product ID: 504364
This is part of FDA's Total Product Life Cycle paradigm coupled with an effective Corrective and Preventive Action (CAPA) program. However, the FDA provides little guidance on how to manage recovery from failed cybersecurity operations. What should your cybersecurity include? FDA is relying more and more on the use of voluntary standards developed from a number of sources and expects you to do the same.

Objectives of the Presentation
  • Understand the need for an effective and up-to-date cybersecurity program
  • Identify the fundamental cybersecurity management concepts
  • Identification of key voluntary standards and the role of the National Institute of Standards and Technology (NIST)
  • Identify training needs for employees
  • Providing key points of an effective cybersecurity management program
Why Should you Attend
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. 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.

Areas Covered
  • Initial steps to building a cybersecurity preventive program
  • Basic components of a cybersecurity CAPA program
  • Human Resources Requirements
  • Cyber attack Recovery Components
  • Cybersecurity Program Checklist
Who will Benefit
  • Device Manufacturers
  • Software Engineers
  • Design specification developers for hardware/software devices
  • Information technology managers and administrators
  • Software Forensic Engineers
  • Regulatory Affairs Managers/Directors
  • Quality Assurance Managers and Consultants
  • Regulatory Program and Procedures Developers
  • Complaint Investigation Team Managers
  • Programmers and Logistics Managers for Risk Mitigation
  • Recall Managers
$299
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Instructor Profile:
Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.
Bar Admissions: Massachusetts, 1986 and District of Columbia, 2011
Education: Suffolk University Law School, Boston, Massachusetts, 1986.
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