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 )
  • OverView
  • Why attend
  • Agenda
  • Venue
  • Who will benefit
  • Speaker
  • Local attractions

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

  • Business Planning Executives
  • Regulatory Directors
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business acquisition Managers
  • Owners of New or Developing Import/Export Firms
  • International Trade and Logistics Managers
  • Import Brokers
  • Investors
  • Sales Managers

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.

test The Sixth Floor Museum at Dealey Plaza is located on the sixth floor of the Dallas County Administration Building in downtown Dallas, Texas, overlooking Dealey Plaza at the intersection of Elm and Houston Streets. Comprehensive exhibits on John F. Kennedy's presidency & assassination at site of the sniper's nest.    

 70-acre botanical garden set on White Rock Lake with frequent concerts, special exhibits & classes.The Dallas Arboretum and Botanical Garden is located at 8525 Garland Road in East Dallas, Dallas, Texas, on the southeastern shore of White Rock Lake.

 

Seminar 12 The Dallas World Aquarium is a for-profit aquarium and zoo located in the West End Historic District of downtown Dallas, Texas, USA. It aids conservation and education by housing many animals that are threatened or endangered as part of a cooperative breeding program with other zoos around the world.

 

Seminar 2 The Dallas Museum of Art is an art museum located in the Arts District of downtown Dallas, Texas, along Woodall Rodgers Freeway between St. Paul and Harwood. In 1984, the museum moved from its previous location in Fair Park to the Arts District and is the anchor with an encyclopedic collection spanning ancient times to the present.

 

 

For group or any booking support, contact: