Revolutionary Change in FDA Software Regulation
Short course
Online
*Indicative price
Original amount in USD:
$ 150
Description
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Type
Short course
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Level
Advanced
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Methodology
Online
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Class hours
1h
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Duration
1 Day
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Start date
Different dates available
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Virtual classes
Yes
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.
Facilities
Location
Start date
Start date
Reviews
Subjects
- Health Management
- Management
- Education Studies
- Quality
- Healthcare
- Technology
- Medical
- Organizational Skills
- Knowledge management
- Clinical
Teachers and trainers (1)
Adam Fleming
Event Manager
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 has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements.
Course programme
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 ImpactSoftware no longer under FDA jurisdictionChanges in premarket requirementsVoluntary controls short cutsPostmarket reporting optionsDigital Health Initiative - FDA clearance not required
Who Will Benefit:Regulatory Affairs DirectorsSoftware Designers / Specification DevelopersProduction ManagersQuality Assurance DirectorsIn-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: +1-800-447-9407Email: support@compliance4All.com
Additional information
Revolutionary Change in FDA Software Regulation
*Indicative price
Original amount in USD:
$ 150