The "Validation of FDA-Regulated Systems Used in Drug Development & Submissions Using Artificial Intelligence (AI), Machine Learning (ML) & Large Language Models (LLMs), such as ChatGPT (August 28, 2025)" training has been added to ResearchAndMarkets.com's offering.

Providing safe and effective 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. You will learn about projects going on in industry and at FDA that take advantage of Artificial Intelligence (AI), Machine Learning (ML) and Large Language Models (LLMs), such as ChatGPT.

With newer technologies such as AI, ML and LLMs in the mix, it means opportunity for greater efficiency and efficacy, but also poses 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, ML and LLMs like ChatGPT can increase efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative drugs that will drive industry over the coming years.

You should attend this webinar if you are responsible for planning, executing or managing the development or implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with FDA.

Who Should Attend:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts and Managers
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs and Submissions Specialists
• Clinical Data Analysts and Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Vendors and consultants involved in life sciences software validation and compliance

Key Topics Covered:

• How AI is being increasingly used in the life sciences industry to enhance drug safety and effectiveness
• Potential risks and challenges related to AI, ML, and LLMs such as ChatGPT
• Challenges facing the industry today and how AI technologies can help
• FDA's adaptation for reviewing AI-enabled software used in drug manufacture and quality testing
• Understanding how drug products relying on AI are regulated by the FDA
• Impacts and risks to data, processes, products, and patients
• Strategies to ensure the benefits of drugs outweigh the risks
• How FDA, Congress, and industry are collaborating for AI adoption
• Best practices to improve compliance of AI-enabled drugs
• Validation, FDA Part 11, and data integrity for AI/ML systems
• Insights into FDA's CSA guidance and GAMP5, 2nd Edition
• Software validation and maintenance requirements for AI integration

Speaker

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.

For more information about this training visit https://www.researchandmarkets.com/r/1l4klk

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251107607315/en/