Course 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.
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
Webinar Takeaway
During the webinar, we will discuss the following:
- 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 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 drugs and medical devices that have the ability to evolve rapidly in response to new data, sometimes in ways difficult to foresee.
- Learn 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.
- Understand 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.
- 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 products that leverage AI 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.
- 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
Background
In June 2025, FDA announced plans to use AI to speed new drug and medical device approvals. Elsa is a tool that may enhance FDA review of safety data, summarize reports and flag facilities needing inspection. Built within a high-security GovCloud environment, it offers a secure platform for FDA staff to access internal documents while ensuring information remains within the agency. Clinical protocol reviews could be considerably shortened.
Learn more about how FDA and life science companies are using AI and ChatGPT. This is expected to improve efficiency while enabling FDA and companies to run more smoothly. This is critical at a time when we are faced with a rising demand for healthcare, expansion of specialty medicines and physician shortages. Leveraging comprehensive data systems will lead to greater efficiency in diagnosis and treatment planning, and integration of patient data facilitates personalized medicine approaches for more effective interventions.
But this webinar doesn’t stop there!
We’ll provide an overview of computer system validation, including the draft guidance from FDA on Computer Software Assurance (CSA), and the latest GAMP®5, 2nd Edition that aligns with CSA. We’ll walk you through the Software Validation and Maintenance approach that will bring clarity to what FDA is looking for.
Faculty Carolyn Troiano (45+ yrs exp.)
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.
