6-Hour Virtual Seminar on FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use



The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public health concern. Part of that risk involves the intentional activity that can conflict, intrude or destroy software. The problems are taking center stage in the "healthcare software" dialogue.

 

What issues can compromise or defeat the functional use of your software? Poor cybersecurity programs, lack of interoperability with third-party software, the wave of unmanageable apps and wireless home use technology.  Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.

 

Why you should attend

 

  • FDA's changing regulatory controls
  • Cybersecurity management by design, oversight and preventive action
  • Ransomware attacks and recovery
  • Use voluntary standards and NIST
  • Mobile apps regulated and those not regulated
  • Wireless/home use software systems and human factors

 

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 and Presenter Information

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. 


Event Type
Webcast


This event has no exhibitor/sponsor opportunities


When
Mon, Mar 16, 2020, 8:00am - 2:00pm PT


Cost

Virtual Seminar Ticket:  $545.00


Website
Click here to visit event website


Organizer
GlobalCompliancePanel


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