Revolutionary Change in FDA Software Regulation
ENDED
Training by
Compliance4All
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On-Site
/ Training
USD 150.00
Details
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: [email protected]
http://www.compliance4all.com/control/w_product/~product_id=501933LIVE?channel=speedycourse_Aug_2018_SEO
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: [email protected]
http://www.compliance4all.com/control/w_product/~product_id=501933LIVE?channel=speedycourse_Aug_2018_SEO
Outline
Special Offer
One Dial-in One Attendee
Price: $150.00
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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. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting 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. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
