Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

Carolyn Troiano

Carolyn Troiano

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects.
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90 Mins
Carolyn Troiano

The biotechnology, pharmaceutical, medical device, biological, and tobacco and tobacco-related product industries are among the life science businesses that continue to adopt new technologies to enhance the delivery of high-quality products that adhere to FDA regulations. 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.

Webinar Objectives

Join industry expert Carolyn Troiano in this webinar as she discusses how artificial intelligence (AI) can enhance the efficiency and effectiveness of software development life cycle (SDLC) activities in the life sciences industries, particularly in the context of FDA-regulated products. With the increasing threat of cyberattacks targeting medical devices and other FDA-regulated products, it is crucial for companies to understand and implement strategies to prevent and mitigate these risks.

The session will delve into the current landscape of cyber threats facing medical devices and how the industry is responding to these challenges. Carolyn will explore industry best practices for identifying and addressing sources of threats to ensure the safety and effectiveness of FDA-regulated products. 

This webinar is designed for professionals working in FDA-regulated industries, including pharmaceuticals, medical devices, biological products, animal health, and tobacco. Relevant functions include research and development, manufacturing, quality control, distribution, clinical testing and management, adverse events management, and post-marketing surveillance.

If you are involved in planning, executing, or managing the development or implementation of systems governed by FDA medical device or software regulations, or if you are responsible for maintaining or supporting such systems, this webinar is essential for you. Join us to learn how AI can drive industry advancements and help you navigate the evolving regulatory landscape.

Webinar Agenda

•    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

Webinar Highlights

•    Learn about how AI increasing in use in the life sciences industries, and how companies are leading the way to delivering more effective, safer, and more beneficial products as a result.
•    Learn about the challenges and vulnerabilities facing industry today.
•    Learn what FDA is doing to confront the increase in cyberthreats posed with the advent of newer technologies and what further work may be done.
•    Learn about the potential impact and risk threatening data, processes, products, and ultimately patients based on these.
•    Learn about industry best practices for implementing, validating, meeting FDA Part 11 and data integrity requirements, as AI applications improve operational efficiency and effectiveness in the process.

Who Should Attend

  • 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
  • Personnel in the following roles will benefit:
    • Information Technology Analysts, Developers, Testers, 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
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