FDA’s Unprecedented Changes in Software Regulation

Product Id IQS18L1214
Speaker Casper Uldriks
Level Basic & Intermediate
Timings 09:00 AM TO 04:30 PM CST
Scheduled Date(s) Thursday, December 13, 2018 to Friday, December 14, 2018 ( 2 Days )
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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 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 in one of three ways: standalone, such as for a mobile app; device-based software used to control a device’s performance; or simply electronic records. FDA’s risk classification will gradually clarify how it intends to manage the health risks with new premarket controls and postmarket options. The FDA did not foresee the cancer of cybersecurity attacks, interoperability failures, the massive use of wireless communication, and mobile apps.

  • Understand FDA’s risk-based regulatory strategy
  • Learn how FDA and other federal components are trying to keep pace cybersecurity attacks
  • Highlight the problems of interoperability and what you can do about it
  • Familiarize you 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 revision of regulating mobile apps
  • Learn about the changes in premarket and postmarket policies
  • Learn how software recalls present new procedural issues
  • FDA’s legal authority and regulatory plan
  • New premarket and postmarket controls
  • Cybersecurity management
  • Ransomware attacks and recovery
  • Use voluntary standards and NIST
  • Mobile apps
  • Software recalls

Location: Dallas, TX

Venue: To Be Decided

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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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