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Site language : English - Français
Ref : 27504
Event :Revolutionary Change in FDA Software Regulation

Date :Tuesday August 28th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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
http://www.compliance4all.com/control/w_product/~product_id=501933LIVE?channel=doctorama_Aug_2018_SEO

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

Revolutionary Change in FDA Software Regulation Medicine - Pharmacy - Bio-Technologies - Toxicology - Public Health
education, health, medical device
Everyone, Regulatory Affairs Directors Software Designers / Specification Developers Production Managers Quality Assurance Directors In-House Legal Counsel
50 1 --
English

Other

For more information on Revolutionary Change in FDA Software Regulation, plsase contactr Compliance4All

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