• Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
  • Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)

    • Speaker : Carolyn Troiano
    • Session Code : CTFEB2324
    • Date : 23rd February 2024
    • Time : This Event is Over and the Recorded Content is Available
    • Duration : 90 Mins



As the life sciences industry, encompassing pharmaceuticals, medical devices, biotechnology, and other FDA-regulated sectors, progressively adopts advanced technologies like Artificial Intelligence (AI) and Machine Learning (ML), the imperative for stringent validation of these systems has never been more critical. The integration of AI not only promises to revolutionize product development, testing, and management through enhanced efficiency and innovation but also introduces complex challenges in ensuring these systems' security against increasing cyber threats.


In today's digital age, cybersecurity has emerged as a paramount concern. Cyberattacks pose a significant risk, capable of undermining the integrity and functionality of medical devices and software applications. The inclusion of AI technologies further amplifies these risks, necessitating robust strategies for the validation of computer systems to maintain compliance with FDA regulations, particularly 21 CFR Part 11 (Electronic Records and Electronic Signatures), and to ensure the utmost data integrity and system security.


The FDA has signaled its awareness and concern regarding the industry's efforts to meet these compliance standards amidst the rapid adoption of new technologies. With citations for non-compliance on the rise, it is evident that the industry faces pressures to innovate responsibly, balancing the drive for technological advancement with the critical need for security and compliance.


This webinar aims to address the dual challenges of navigating the evolving landscape of AI and ML technologies in the life sciences sector and fortifying these innovations against cyber threats. Attendees will gain insights into the regulatory expectations for the validation of FDA-regulated systems incorporating AI, the specific challenges posed by cybersecurity, and the best practices for ensuring that these cutting-edge technologies enhance, rather than compromise, the delivery of safe and effective products.


Areas covered in this session:


  • 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.
  • Collaborative efforts required among FDA, Congress, technology developers, and healthcare industry companies to establish best practices for AI and ML applications.


Why Should You Attend?


In the rapidly evolving landscape of life sciences, where Artificial Intelligence (AI) and Machine Learning (ML) technologies are increasingly integrated into FDA-regulated systems, the process of validation stands as a critical pillar ensuring both compliance and security. This webinar caters to industry professionals who are navigating the intricate balance between embracing technological advancements and adhering to stringent regulatory standards, with a special focus on the validation of systems against cybersecurity threats.


Understanding the validation process for FDA-regulated systems that utilize AI and ML is imperative, not just for regulatory compliance, including adherence to 21 CFR Part 11, but also for fortifying these systems against the burgeoning spectrum of cyber threats. This session will equip you with comprehensive strategies for the effective validation of these sophisticated systems, embedding cybersecurity measures as a core component of the validation process.


By joining us, you will gain insights into the FDA's regulatory framework as it adapts to encompass AI and ML technologies, and learn how to conduct thorough validation processes that not only meet FDA standards but also address the unique cybersecurity challenges posed by these technologies.

This webinar is essential for professionals striving to ensure that their AI and ML-powered systems are not only innovative and efficient but also secure and compliant within the FDA-regulated environment.


What industries will benefit from your training:


Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:


  • Pharmaceutical (for drug products introduced using a medical device)
  • Medical Device
  • Biologicals (for biological products introduced using a medical device)
  • Tobacco (based on the Tobacco Control Act of 2009)
  • E-Liquid/Vapor (based on the “Deeming” Act of 2016)
  • E-Cigarette (based on the “Deeming” Act of 2016)
  • Cigar (based on the “Deeming” Act of 2016)
  • Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
  • Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit:


Personnel in the following roles will benefit:


  • Information Technology (IT) Analysts
  • IT Analysts, Developers, and Testers
  • IT Support Personnel
  • QC/QA Managers
  • QC/QA Analysts
  • Clinical Data Managers
  • Clinical Data Scientists
  • Analytical Chemists
  • Compliance Managers
  • Laboratory Managers
  • Automation Analysts
  • Manufacturing Managers
  • Manufacturing Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Carolyn Troiano has more than 40 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. 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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Tags: FDA AI Compliance, ML Validation, Cybersecurity in Healthcare, AI System Validation, Life Sciences Cybersecurity, FDA Regulation Webinar, AI Technology Regulation, Healthcare ML Applications, Medical Device AI Security, Biotech AI Compliance, Carolyn, Troiano, February 2024, Webinar