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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Carolyn Troiano
Recording Webinar Available @All Days
Recorded Webinar
  

Description

This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products.  Protecting medical devices from hacking where someone can alter the actual code embedded in the device could result in injury or death to a patient or consumer.  A serious threat, it must be dealt with at all levels to make sure the end product being used by a patient or consumer is perfectly safe and delivers the effective treatment required.

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.

Cybersecurity is a serious concern for medical device safety and effectiveness.  Without protection, software running on a medical device could cause severe injury or death to a patient.

There are many forms of cybersecurity and many remedies for thwarting attempts to penetrate medical device software.  Most of these are based in physical and logical security practices that are becoming best industry practices.

This webinar will detail some of the threats and ways to mitigate them to protect consumers from harm.

This webinar benefits the following agencies-

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

  • Pharmaceutical
  • Medical Device
  • Biologicals
  • Tobacco
  • E-Liquid/Vapor
  • E-Cigarette
  • Cigar
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
  • Colleges and Universities offering programs of study for Compliance of Systems Regulated by FDA

Who should attend?

  • Information Technology (IT) Analysts
  • IT Developers
  • IT Support Staff
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Lab Managers and Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders using Computer Systems regulated by FDA
  • Regulatory Affairs Personnel
  • Consultants in the Life Sciences and Tobacco Industries
  • Interns working at the companies listed above
  • College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

Training Options

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Recording
   $199  

Digital Download
   $229  

Transcript (PDF)
   $199  

Tokyo

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