Training Overview

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

Webinar Includes : All the training handouts , certificate ,Q/A and 4 hrs Live Webinar

Training Agenda

Module 1: (1 Hour) 11:00 AM -12:00 PM EDT

Software and Medical Devices

Vulnerability and Challenges

FDA Guidance

Other FDA Activities

Medical Device Software Changes

Module 2: (1 Hour) 12:00 - 12:45 PM EDT

IEC 62304 Compliance

Software Quality Assurance (SQA) Plan

FDA Pre-Certification Pilot Program

FDA Guidance - Best Practices

FDA Regulatory Oversight & Inspection

Break for 15 mins

Module 3: (1 Hour) 01:00 -02:00 PM EDT

System and Data Integrity

GxP Systems

Computer System Validation (CSV)

System Development Life Cycle (SDLC) Methodology

GAMP®5 Software Categorization

System Risk Assessment

Module 4: (1 Hour) 02:00 - 03:00 PM EDT

CSV Support

The Future of Cybersecurity and FDA Compliance

Recap

Q&A

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.

This is of particular concern for software that is incorporated in a medical device, is used in conjunction with a medical device, and Software as a Medical Device (SaaMD).

Who will Benefit

Personnel in the following roles will benefit:

  • Information Technology Analysts
  • Information Technology Developers and Testers
  • Software Quality Assurance Professionals
  • QC/QA Managers and Analysts
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Specialists and Managers
  • Supply Chain Specialists and Managers
  • Regulatory Affairs Specialists
  • Regulatory Submissions Specialists
  • Risk Management Professionals
  • Clinical Data Analysts
  • Clinical Data Managers
  • Clinical Trial Sponsors
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Vendors responsible for software development, testing and maintenance, including those delivering Software used in, or in conjunction with a medical device, Software as a Medical Device (SaaMD) and systems and applications used by these FDA-regulated industries
  • Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance


Faculty Carolyn Troiano

Carolyn Troiano 

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

Choose a Purchase Option


$595

One Dial-in One Attendee - Live + 90 days Access

Early Bird $595 Regular Price $995

You get one log-in for the live 4 hrs webinar for one participant, presentation materials and the opportunity to ask questions by phone and email. On Demand Access for 90 days is included .

$895

Group-Max. 10 Attendees - Live + 12 month Access

4 hrs Webinar

You get 10 log-in for the live 4 hrs webinar for all the participant, presentation materials and the opportunity to ask questions by phone and email. 12 month Recorded access is included

$598

Recorded Access Single Participant

You'll have 12 month single user access to log-in for an archived recording of the entire 4 hrs webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

$1,495

Recorded Access Corporate Group

You'll have 12 month group access to log-in for an archived recording of the entire 4 hrs webinar, including the Q&A period . You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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