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Webinar On Webinar On FDA Regulation of
Mobile Apps
Presented By Casper E. Uldriks
Contact Us: 416-915-4458
Hosting By
Compliance Trainings
Please visit us at https://compliancetrainings.com
Scheduled on Thursday, April 16, 2015 at 13:00 Hrs
Contact Us: 416-915-4458
We Empower, You Comply!
Webinar Description:
FDA Regulation of Mobile Apps
The use of mobile apps as a medical device continues to
mushroom. Approximately 85% of adults use cellphones. They offer a fertile field
for mobile apps used for medical purposes, some good, some not. How do you
decide which healthcare app is safe? Can someone hack an app you rely on for life
supporting / life sustaining medical care? Yes. Patients and caregivers receive and
install “app updates” with no idea what just happened and place themselves and
even others in jeopardy. FDA has started to implement a regulatory approach and
is overwhelmed now with that task. How much can FDA do? How will you know
about the risks faced by the healthcare sector and you as an individual?
FDA is not the only regulatory stakeholder. The FTC exercises overlapping
regulation. Are the two agencies in-sync with each other? Each agency is
concerned about false or misleading claims. Marketers of standalone medical app
software may have no clue about the FTC’s and FDA’s regulatory purview and
enforcement authority over how a mobile app is marketed. That knowledge gap
can be brutal, expensive and bring your business to a standstill.
Product Id FDB1551
Category Food, Drugs & Biologics
Scheduled On Thursday, April 16, 2015 at 13:00 Hrs
Duration 60 Minutes
Speaker Casper E. Uldriks
Login at https://compliancetrainings.com/siteengine/Login.aspx
Areas Covered in the Session :
Who Will Benefit :
Practice Managers
MD's and other Medical Professionals
Billing Companies
Transcription Companies
IT Companies
Answering Services
Home Health
Coders
Attorneys
Any business associates who work with medical practices or hospitals
Live
Single Live : For One Participant
$ 189
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
Price Tags
Areas Covered in the Session :
FDA Strategy and Policy
Medical App Definition
Institutional and Home Use Risks
Cyber Security
Labeling Claims
Enforcement
To Register This Webinar Please Visit
https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1551
Contact Us For Immediate Assistance
@ 416-915-4458
or Mail Us At
uttam@compliancetrainings.com
support@compliancetrainings.com
Casper (Cap) Uldriks 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 as 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. He is recognized as an exceptional and energetic speaker. His
comments are candid, straightforward and of practical value. He understands
how FDA thinks, operates and where it is headed. Cap is the President of
Encore Insight LLC, a consulting and training service for FDA law and
operations.
Speaker Profile

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Fda Regulation Of Mobile Apps

  • 1. Webinar On Webinar On FDA Regulation of Mobile Apps Presented By Casper E. Uldriks Contact Us: 416-915-4458 Hosting By Compliance Trainings Please visit us at https://compliancetrainings.com Scheduled on Thursday, April 16, 2015 at 13:00 Hrs
  • 2. Contact Us: 416-915-4458 We Empower, You Comply! Webinar Description: FDA Regulation of Mobile Apps The use of mobile apps as a medical device continues to mushroom. Approximately 85% of adults use cellphones. They offer a fertile field for mobile apps used for medical purposes, some good, some not. How do you decide which healthcare app is safe? Can someone hack an app you rely on for life supporting / life sustaining medical care? Yes. Patients and caregivers receive and install “app updates” with no idea what just happened and place themselves and even others in jeopardy. FDA has started to implement a regulatory approach and is overwhelmed now with that task. How much can FDA do? How will you know about the risks faced by the healthcare sector and you as an individual? FDA is not the only regulatory stakeholder. The FTC exercises overlapping regulation. Are the two agencies in-sync with each other? Each agency is concerned about false or misleading claims. Marketers of standalone medical app software may have no clue about the FTC’s and FDA’s regulatory purview and enforcement authority over how a mobile app is marketed. That knowledge gap can be brutal, expensive and bring your business to a standstill. Product Id FDB1551 Category Food, Drugs & Biologics Scheduled On Thursday, April 16, 2015 at 13:00 Hrs Duration 60 Minutes Speaker Casper E. Uldriks Login at https://compliancetrainings.com/siteengine/Login.aspx Areas Covered in the Session :
  • 3. Who Will Benefit : Practice Managers MD's and other Medical Professionals Billing Companies Transcription Companies IT Companies Answering Services Home Health Coders Attorneys Any business associates who work with medical practices or hospitals Live Single Live : For One Participant $ 189 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299 Price Tags Areas Covered in the Session : FDA Strategy and Policy Medical App Definition Institutional and Home Use Risks Cyber Security Labeling Claims Enforcement
  • 4. To Register This Webinar Please Visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1551 Contact Us For Immediate Assistance @ 416-915-4458 or Mail Us At uttam@compliancetrainings.com support@compliancetrainings.com Casper (Cap) Uldriks 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 as 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. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations. Speaker Profile