How to avoid your medical device being hacked

Carolyn Troiano

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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 in the Session :

• 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

Who will benefit:

Medical Device manufacturing, Testing, Packaging and Distribution companies.

In some cases, the medical device software will be provided by a software development firm vs. the medical device company itself.

In some cases, the medical device will deliver a drug to a patient, and so those working in the pharmaceutical and/or biotechnology industries may have some interest in this topic.

All FDA-regulated industries:

• Pharmaceutical (some have a combination product, a medical device that delivers a drug)

• Biologicals (some have a combination product, a medical device that delivers a biological)

• Medical Device

• Tobacco (the regulations have not been formalized yet, so these may apply to this industry)

• e-Liquid, Vapor and Cigar companies (the regulations have not been formalized yet, so these may apply to this industry)

• Software vendors providing code to medical device companies for incorporation into their products

Specific Titles:

• Information Technology Analysts

• Information Technology Developers and Testers

• Quality Control/Quality Assurance Managers and Analysts

• Quality Auditors

• Compliance Officers

• Analytical Chemists

• Laboratory Managers

• Automation Analysts

• Manufacturing Directors, Supervisors and other key personnel

• Warehouse and Supply Chain Directors, Supervisors and other key personne

• Computer System Validation Specialists

• GMP Training Specialists

• Business Stakeholders/Subject Matter Experts

• Business System/Application Testers

• Clinical Data Managers and Scientists

• Quality Managers, Chemists and Microbiologists

• Regulatory Affairs Personnel

• Adverse Event and Post-Marketing Surveillance Specialists

• Consultants in the Life Sciences, Tobacco and Related Industries

Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity.

Finally, anyone who is developing and maintaining software used in these industries should be aware of the requirements for data integrity for their systems.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Carolyn Troiano,

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. 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. Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.

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