Medical Device Cybersecurity and FDA Compliance

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Listen By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms."

Cybersecurity is a serious concern for medical device safety

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..

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

This webinar will cover the following key areas:
•            Provide an overview of cybersecurity and guidance on device software
•            Provide an overview of the most common problems faced by industry in terms of medical device security,                    efficacy, and safety
•            Provide a set of best practices and industry standards to meet the challenges of cybersecurity and other                    threats to devices and software
•             Q&A

Who will Benefit

Professionals in the following industries may also benefit from the content:
     •         Pharmaceutical
     •         Medical Device
     •         Biotechnology
     •         Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
     •         Information technology managers and analysts
     •         QC/QA managers and analysts
     •         Clinical data managers and scientists
     •         Compliance managers
     •         Lab managers and staff
     •         Automation analysts
     •         Computer system validation specialists
     •         GMP training specialists
     •         Business stakeholders and individuals who are responsible for computer system validation planning,                          execution, reporting, compliance, and audit
     •         Consultants working in the life sciences, tobacco and related industries who are involved in computer                          system implementation, validation and compliance

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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