FDA's Problem with Software Monsters


Tuesday, February 5, 2019   |   10:00 AM PST | 01:00 PM EST   |   Duration: 60 Minutes      

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Duration: 60 Minutes  

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By attending this webinar attendees will learn about FDA's risk-based regulatory strategy, Also Learn where FDA and you can find current technical help.
Casper Uldriks   Product Id : 502334
  Instructor : Casper Uldriks

  More Trainings by this Expert


Overview:

Software's level of complexity and use keeps expanding at exponential levels. Likewise, the potential risks to health and loss of privacy follow suit. Ransomeware attacks hold software programs hostage until you pay the culprit thousands of dollars.

Life supporting and life sustaining health software grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice. FDA looks at software based on the risk to health associated with the software's use.

Cybersecurity problems for software for life sustain devices, wireless networks for patient manage and home use devices open the gate for cyber intrusion, functional malware and total denial of access denial to an entire network of software, such as that used in hospitals and clinics. Who will help you? This becomes a self-help scenario; FDA and the FBI cannot protect you from the "bad guy." An equally disastrous problem involves interoperability failures.

If your software does not cross the bridge of software communication, that software becomes worthless. Wireless technology, mobile apps and home use of software-based devices raise endless vulnerabilities. How you protect yourself and your customers in this swamp of disasters is critical.

Why should you Attend:

  • FDA's regulatory controls
  • Cybersecurity management
  • Ransomware attacks and recovery
  • Use voluntary standards and NIST
  • Mobile apps
  • Wireless/home use software systems

Areas Covered in the Session:
  • Understand FDA's risk-based regulatory strategy
  • Learn where FDA and you can find current technical help
  • Highlight the problems of interoperability and what you can do about it
  • Familiarize yourself with the National Institute of Standards and Technology's (NIST) role in cybersecurity prevention and interoperability considerations
  • Learn about the FDA's increased use of voluntary standards
  • Clarify FDA's ongoing revision of mobile app regulation

Who Will Benefit:
  • Business Planning Executives
  • Regulatory Directors
  • Software Design and Specification Developers
  • Real time Software Performance Auditors
  • Recall Managers
  • In-house Legal Counsel
  • Customer Support and Service Directors
  • Contract Specialists
  • Business Acquisition Managers
  • Hospital Risk Managers


Speaker Profile
Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. He specialized 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. His comments are candid, straightforward and of practical value. He 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. Professional credentials: 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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