Validation of Systems Using Artificial Intelligence (AI), Machine Learning (ML), Blockchain and ChatGPT for FDA Compliance

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), Machine Learning (ML), Blockchain and Large Language Models (LLMs), including ChatGPT are 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, ML, Blockchain and ChatGPT and others are 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 newer technologies in software development, testing, and support.

It is time to embark on the latest technology 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. There is ample opportunity as we embark on implementing newer, innovative technologies, such as AI, ML, Blockchain and ChatGPT for use in systems regulated by FDA.

One of the largest current threats to medical 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 these innovative technologies 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 is to try to stay ahead of the curve, but this is increasingly more challenging and difficult.  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, regulatory submissions, 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. You should also attend to learn what role these advanced technologies may play in the future of product delivery, making your operations more efficient while meeting FDA compliance requirements.

Areas Covered in the Session :

• Learn about how AI and ML are 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 Blockchain for use in ensuring data integrity compliance.
• Learn about ChatGPT and other LLMs that can make operations vastly more efficient, while still meeting compliance requirements.
• Learn about the challenges and vulnerabilities facing industry today.
• 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, ML, Blockchain and ChatGPT in health care and the challenges posed.
• How and under what circumstances products relying on AI are regulated by FDA.
• Learn about the potential impact and risk threatening data, processes, products, and ultimately patients based on these tools being misused, and often misunderstood.
• Learn how to ensure benefits of products outweigh risks.
• 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.
• 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 innovative technology in operational processes in today’s FDA-regulated companies.
• Industry best practices and recommendations for improving compliance of products that leverage innovative technology in operational processes.
• Learn about industry best practices for implementing, validating, meeting FDA Part 11 and data integrity requirements, as AI, ML, Blockchain and ChatGPT applications improve operational efficiency and effectiveness in the process.

Who Should Attend:

IT, R&D, Manufacturing, QA, Regulatory, Clinical, Supply Chain, & Business Managers & Professionals who need to:

• Manage or participate on computer system projects requiring validation that include software involving AI, ML, Blockchain and/or ChatGPT.
• Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, UAT), Test Plans, and Test Reports.
• Understand the process of computer system validation and what is, and is not required by FDA. We’ll explore a variety of myths on the subject.
• Author, implement, or upgrade Validation policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
• Understand the FDA and international regulatory landscape around Validation, Electronic Records/Signatures, data integrity and other compliance areas.

This webinar is intended for those involved in planning, execution and support of computer system development, testing, validation and support activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, regulatory submissions, and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers, Testers & System Stewards
• QC/QA Managers & Analysts
• Analytical Chemists and those working in other areas of Biologics and Chemistry
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Contract Research Organizations (CROs)
• Computer System Validation, 21 CFR Part 11 & Data Integrity Compliance Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers

This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system development, testing, implementation, validation, support & compliance.

Course Director: 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. 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.