Overview
Using AI in Regulated Systems? Make Sure It’s FDA-Compliant.
AI and machine learning are rapidly transforming drug development, data analysis, and regulatory submissions. But with this shift comes a critical question:
Are your AI-driven systems properly validated and compliant with FDA expectations?
Without the right validation approach, the use of AI tools—including modern LLMs like ChatGPT—can introduce serious compliance risks, data integrity concerns, and potential audit findings.
This training provides a practical, regulatory-focused framework to help you confidently use AI while ensuring your systems remain compliant, validated, and audit-ready.
AI is no longer experimental in pharma—it’s already embedded in how data is generated, reviewed, and submitted. But while adoption is accelerating, compliance expectations haven’t been simplified. Unvalidated AI systems can introduce hidden risks, from unreliable outputs to serious data integrity concerns that surface during audits. This training equips you with a clear, practical approach to bringing control, structure, and confidence to AI-enabled systems—including tools like ChatGPT. Learn how to evaluate risk, apply validation where it matters, and build defensible, inspection-ready systems—so you can move forward with innovation without exposing your organization to compliance gaps.
Why This Training Matters Now
Organizations across pharma and biotech are already integrating AI into:
- Drug development workflows
- Data analysis and reporting
- Regulatory submissions
- Quality and compliance processes
What You Will Learn
By the end of this program, you will be able to:
✔ Identify when AI/ML systems fall under FDA regulatory scope
✔ Apply a risk-based validation approach to AI-driven systems
✔ Ensure data integrity, traceability, and documentation
✔ Understand challenges like model drift, bias, and reliability
✔ Use AI tools in a way that aligns with regulatory expectations
✔ Build audit-ready validation strategies for AI-enabled workflows
Practical, Real-World Focus
This is not a theoretical session. You will gain:
- Real-world use cases
- Practical validation strategies
- Clear guidance aligned with FDA expectations
- Actionable steps you can implement immediately
What’s Included
- Live expert-led session
- Practical frameworks and methodologies
- Real-world examples and case discussions
- Interactive Q&A
- Certificate of Completion
What Makes This Training Valuable
✔ Focused on current AI adoption challenges
✔ Designed for regulated environments (GxP / FDA)
✔ Combines technology + compliance + validation
✔ Helps reduce risk of audit findings and compliance gaps
Ensure your organization is using AI safely, effectively, and compliantly.
Register Now to Stay Ahead of FDA Expectations
Why Should You Attend
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, such as ChatGPT 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, such as 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.
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 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.
Webinar Takeaway
- 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 drugs as a result.
- Learn about the potential risks and challenges related to AI, ML and LLMs, such as ChatGPT.
- Learn about the challenges and vulnerabilities facing industry today, and how these new technologies can provide steps forward.
- Learn about FDA’s considerations for adapting its review process for AI-enabled software used to manufacture and quality test drugs that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
- Learn how and under what circumstances drug 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.
- Understand how to ensure benefits of drugs outweigh risks.
- Understand 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.
- Understand current industry best practices and recommendations for improving compliance of drugs that leverage AI, ML and LLMs, such as ChatGPT in operational processes.
- 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.
- Learn about the FDA’s Computer Software Assurance (CSA) draft guidance and how it aligns with GAMP®5, 2nd Edition.
- Understand the Software Validation and Maintenance requirements to better address compliance with software incorporating AI, ML and LLMs, such as ChatGPT.
- 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
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 45 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.
