The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products continue to embrace new technology to improve delivery of quality products in compliance with FDA. In addition to some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations that have more recently begun to be used more heavily in life science companies, Artificial Intelligence (AI) is beginning to find a presence at these companies. While life science companies tend to lag behind other markets in using these technologies, they are catching up and we are seeing much more activity related to AI use in software applications used to develop, produce, test, and manage life science products with quality and compliance.

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environments where AI is becoming prevalent.

FDA became alarmed by the lack of compliance to meet data integrity and Part 11 requirements during the last decade. Out of compliance citations during this period, including Form 483s and Warning Letters have skyrocketed for these key areas of compliance. But why?

Based on discussions with clients and stakeholders at conferences and meetings, it has become more and more obvious that most of the performers in industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done, and opens the door to more conversation around the use of AI in software development, testing, and support.

It is time to embark on the AI revolution and continue to deliver quality products with compliance to meet the needs of the consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for FDA.

Why Should You Attend

Providing safe and effective medical devices, drugs, and other FDA-regulated products 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. And with newer technologies such as AI in the mix, it means more challenges for companies that develop, test, and support software applications in the life science industries.

In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions that will drive industry over the coming years.

 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 webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the development or implementation of any system governed by FDA medical device or software regulations, or if you are maintaining or supporting such a system.

Webinar Takeaway

This webinar will cover the following key areas:

  • How FDA will adapt its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
  • An overview of current and potential uses of AI in health care and the challenges posed.
  • How and under what circumstances products using AI are regulated by FDA.
  • FDA’s plans to ensure benefits of products involving AI technology outweigh the risks.
  • FDA, the US Congress, technology developers, and health care industry companies must work together to determine and share best practices for using and working with AI.
  • Q&A

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
  • Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

Description of the topic

During the webinar, we will discuss the following:

  • FDA’s considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
  • Current and potential uses of AI in health care and the challenges posed.
  • How and under what circumstances products relying on AI are regulated by FDA.
  • How to ensure benefits of products outweigh risks.
  • How FDA, Congress, technology developers, and health care industry must work together to forge this new path and lead to a deeper and broader application of AI in operational processes in today’s FDA-regulated companies.
  • Industry best practices and recommendations for improving compliance of products that leverage AI in operational processes.

Faculty Carolyn Troiano 

Consulting/Training in FDA Compliance for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity

Carolyn Troiano has more than 40 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.

This course is closed for enrollment.


RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

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