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Revolutionary Change in FDA Software Regulation
Presented By Netzealous LLC DBA - Compliance4All
Tuesday, August 28th at 10:00am PST
Online sale ends: 08/28/18 at 9:00am PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Fremont, CA 94539
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Talent
Description
Overview: 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: 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. Event Fee: One Dial-in One Attendee Price: US $150.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com |
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10:00am to 11:00am
General Admission: $150.00
All Ages
50 18004479407 UPCOMING EVENTS
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