FDA's Revolutionary Change in Software Regulation


Tuesday, May 1, 2018   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 60 Minutes          

Live

One Dial-in One Attendee

Price: US$150.00


Corporate Live

Any number of participants

Price:US$290.00


  Duration: 60 Minutes  

Recorded

Access recorded version,
only for one participant ?

Price: US$190.00

Corporate Recorded

Access recorded version,
Any number of participants ?

Price: US$390.00

After attending this webinar, You will learn how to implement faster ways to move products into the marketplace and decide whether or not you want to involve FDA in your cybersecurity problems.
Casper Uldriks   Product Id : 501933
  Instructor : Casper Uldriks

  More Trainings by this Expert


Overview:

Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the benefits where they apply. Your company may even save money, a nice benefit.

Why should you Attend: FDA's regulation of software provides major relief to firms involved with software, especially low risk software. The scope of your program should be re-evaluated to identify your least burdensome approach. You can learn what matters and what does not. You can implement faster ways to move products into the marketplace and decide whether or not you want to involve FDA in your cybersecurity problems. You can prepare now to qualify for the new Digital Health initiative, but you have homework to do first.

Areas Covered in the Session:

  • 21st Century Cure Act Impact
  • Software no longer under FDA jurisdiction
  • Changes in premarket requirements
  • Voluntary controls short cuts
  • Postmarket reporting options
  • Digital Health Initiative - FDA clearance not required

Who Will Benefit:
  • Regulatory Affairs Directors
  • Software Designers / Specification Developers
  • Production Managers
  • Quality Assurance Directors
  • In-House Legal Counsel


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.




Your Recently Viewed Webinars

Payment Methods

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  support@compliance4All.com