Medical Device Cybersecurity Course Overview

In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them. We will discuss the many ways of preventing and mitigating the cybersecurity risk, and about the industry best practices that can help your company do the same.

Webinar Takeaway

This webinar will cover the following key areas:

•Software and Medical Devices - types and definitions (medical devices that use software, Software-as-a-Medical-Device (SaaMD)

•      Vulnerability and Challenges - current state and what direction we're moving in

•      FDA Guidance - guidance on cybersecurity - we'll touch on these guidance documents as they cover monitoring, identifying, and addressing cybersecurity vulnerabilities in medical devices, and we'll touch on Safety Communications sent by FDA

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and FDA Staff

•      Guidance to Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software

Post-market Medical Device Cybersecurity

•      Other FDA Activities - they have some joint efforts with NH-ISAC and Homeland Security

•      Medical Device Software Changes - we'll cover the 510k process in terms of when it must be followed

•      FDA Guidance - Best Practices; we'll cover specific recommendations from FDA to manufacturers and Health Care Facilities; we'll also cover some of the industry standards

•      FDA Oversight and Inspection - we'll cover recent trends, particularly data integrity and 21 CFR Part 11 (electronic records and signatures)

•      System and Data Integrity - we'll cover the basics of data integrity and what FDA is focused on

•      GxP Systems - the types of systems that are regulated by FDA

•      Computer System Validation (CSV) - we'll cover the process for how to validate a system, including the SDLC, GAMPv5, and risk assessment

•      System Development Life Cycle (SDLC)

•      CSV Support - this is to ensure the system remains in a validated state once it's validated

•      The Future of Cybersecurity and FDA Compliance - some of the plans from FDA will be shared

•      Recap


Why Should You Attend this course online

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. Providing safe and effective medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. One of the largest current threats to these devices working safely and effectively is cyberattacks that can wreak havoc on code and device functionality. Preventing these attacks by identifying sources of threats and rooting them out before they can take effect is of the utmost concern.

Who Will Benefit

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Choose a Purchase Option

Faculty Carolyn Troiano

Faculty Carolyn Troiano

  • Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.