Medical Device Cybersecurity and FDA Compliance

Carolyn Troiano
Instructor:
Carolyn Troiano
Date:
Wednesday, February 9, 2022
Time:
10:00 AM PST | 01:00 PM EST
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 504227

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
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Overview:

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, including compliance with IEC 62304. This webinar will detail some of the threats and ways to mitigate them to protect consumers from harm.

Why should you Attend: 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. 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.

Areas Covered in the Session: This webinar includes the following key objectives:

  • Providing safe and effective medical devices is in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use software.
  • This session will provide insight into the IEC 62304 standard as it is applied to medical device software.
  • You will learn how to apply this standard to your own work processes.
  • You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance.
  • Q&A

Who Will Benefit:
  • Information Technology Managers
  • Information Technology Developers
  • Information Technology Analysts
  • Information Technology Testers
  • QC/QA Managers
  • QC/QA Analysts
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for medical device design, development, manufacturing, testing, and distribution
  • Consultants working in the medical device industry
  • Auditors engaged in the internal inspection of medical devices


Speaker Profile
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation.


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