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FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official

Compliance.world

Thursday, December 8, 2016 at 10:00 AM - Friday, December 9, 2016 at 5:00 PM (PST)

FDA's Medical Device Software Regulation & Compliance:...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar - Single registration Not Started $1,299.00 $0.00
(Earlybird Price) Not Started $1,499.00 $0.00

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Share FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official

Event Details

Location: San Francisco
Dates: 8-9 Dec 2016
Duration: 2Days

Speaker:Casper Uldriks

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 Radio-logical Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value.

He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.

Course Description:

The professional healthcare provider and lay people rely more and more on the use of software. It pervades our lives. Likewise, the risks and vulnerabilities of software sneak into our lives. The use of software in medical devices or as a stand-alone product has outpaced the FDA’s ability to keep up with the technology. Likewise, the industry has immersed itself in the development and use of software. The FDA’s regulatory approach has become increasingly stringent in terms of what software developers mush think about and validate. As software technology and its use become more complex and interdependent, the risks associated with problem accelerates and the correction or prevention of problem becomes almost impossible with different proprietary software. Likewise, firm’s must battle hackers. The federal government is using a peculiar approach to regulating software that affects what the FDA does. Software vulnerabilities and associated healthcare risks have a stronghold on patient care and lay use. The industry and the FDA find itself in a race to catch up with it.

For decades, software has been a leading cause for recalls, deaths and serious injuries. The FDA’s regulatory approach uses new premarket and post-market controls to try and reign in a problem that easily runs out of control. The FBI has stated publicly that the healthcare industry and the FDA are the least prepared entities to respond to intentional software corruption. Hospitals' computer systems are routinely hacked, closed down and held ransom. Hackers can shut down a software based device from a remote location or plant malware that makes patient information public. The FBI has stated publicly that the healthcare industry and the FDA are the least prepared entities to respond to intentional software corruption. What does your cybersecurity program cover? Manufacturers also create risks amongst themselves because their products are not inter-operable. Almost all hospitals have experienced this problem to one degree or another. Why would a firm buy your product when it is not compatible with other products it already uses? The federal government has forged new inroads into the problem. Firms must keep pace with the FDA’s demand for software information and design requirements. Likewise, firms must learn how to apply Quality System regulation requirements successfully. Recalls and Medical Device Reports give you away. The current regulatory approach relies not just with the FDA, but in other areas of the federal government. You need to know and follow that evolution of current technology and applicable guidance. These are the kinds of issues that will be highlighted during the seminar.

Learning Objective:

•FDA’s regulatory strategy
•Pre-market and post-market controls
•Interoperability
•Voluntary standards
•National Institute of Science and Technology
•Mobile Apps
•Professional and home use
•Software recalls

Who Will Benefit:

•Regulatory Affairs
•Quality Assurance
•Software Design Engineers
•Manufacturing
•Complaint Dept.
•Hospital Risk Dept.


Agenda :

Day One (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM

Lecture 1:

FDA regulatory strategy

  • Types of Software devices
  • Regulatory strategy
  • Risk classification
    • Function and outcome
  • Medical Device Data Systems (MDDS)
  • Office of the National Coordinator (ONC) for Health Information Protection
  • Software regulatory applications
  • FDA Guidance
    • Premarket submissions
    • Paradigms: aeronautics
  • Quality System Regulation (QSR)
    • Design verification and validation
    • Voluntary standards
    • Corrective and Prevent Action Plans
  • Voluntary standards
  • Recalls:
    • Service / maintenance / recall.
    • Implementation strategy
  • Corrections and Removals reporting
  • Updates: FDA vs. non-FDA
  • Predictive analytics

Lecture2:

Interoperability

  • Compatibility by design
    • Hardware
    • Software
  • Labeling
    • Precautions
    • Instructions for use
  • Use of Voluntary Standards
  • Proprietary information
  • Failure management / follow up
  • User's vs. manufacturer's legal responsibility
    • System configuration
    • Customization
    • Environment of use
      • Professional
      • Home Use

Day Two (8:30 AM - 4:30 PM)

Lecture 1:

Cybersecurity

  • Device vulnerabilities: malfunction and failure
  • Pre-emption design
  • Latent malware/virus
  • Post-event management
    • Corrective action for software
    • Disclosure to users
  • National Institute of Science and Technology Report

Lecture2:

Medical Mobile Applications (mobile apps)

  • Mobile apps defined as a device
  • FDA regulatory strategy
  • FDA guidance
  • National Institute of Science and Technology Report and Collaboration
  • Updates (FDA vs. non-FDA updates)
    • Criteria for corrective and preventive action deemed recalls
    • Reports of Corrections and Removals
    • Reports of adverse events

Professional vs. lay use / home use

  • Labeling: Instructions for use and precautions
  • Environment of use
  • FDA Regulation of accessories
  • Federal Communications Commission (FCC) regulation

 

 Please Click here to Enroll & for more details

Regards,

Joshua

Training Manager

Email: joshua@compliance.world

Call us at : 1-732-7225220

Website: compliance.world

Have questions about FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official? Contact Compliance.world

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When & Where


San Francisco

San Francisco, CA

Thursday, December 8, 2016 at 10:00 AM - Friday, December 9, 2016 at 5:00 PM (PST)


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Organizer

Compliance.world

Compliance.world is established to impart high quality training on governance, regulations and compliance (GRC) through webinars and seminars. We are passionate about processes, procedures, safety and regulations across industries. We value an individual’s right to obtain high quality services and products without discrimination or difference. We understand the importance of compliance to established standards, practices and regulatory frameworks. We encourage professionals, officers and executives from government, industry and Non-governmental organizations to become aware of regulatory frameworks and guidelines. Training them in implementation of these rules and regulations is the best way to encourage and ensure universal compliance. High quality trainings, facilitated by industry experts with decades of experience is our way of contributing towards this cause and we take pride in delivering experience-rich sessions.

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FDA's Medical Device Software Regulation & Compliance: 2-Day In-Person Seminar by Ex-FDA Official
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