Overview

The FDA-regulated industry is changing fast — and artificial intelligence is at the center of that change. The FDA itself deployed an internal AI assistant in 2025 to help staff review documents faster. AI tools are reshaping how regulatory professionals research, write, analyze, and submit. The question is no longer whether AI will impact your regulatory work. It already has. The question is whether you are using it to your advantage. 

In this live webinar, a practicing FDA regulatory consultant and trainer, Dr. Mukesh Kumar, with over 20 years of hands-on industry experience shares exactly how AI has transformed day-to-day regulatory practice — with real examples, real tools, and real results. This is not a theoretical overview of artificial intelligence. It is a practitioner’s session built around the specific tasks that regulatory professionals perform every single day, from drafting SOPs and responding to FDA deficiency letters to decoding complex guidance documents and preparing submission dossiers. 

You will see the actual tools being used, the prompts that generate useful output, and the critical expert review process that ensures every AI-assisted document meets the standards of an FDA-regulated environment. Most importantly, you will walk away with a clear, practical workflow you can begin implementing the same week — no technical background required. 

Why Should You Attend 

Regulatory professionals are under constant pressure to do more with less — tighter timelines, growing submission volumes, expanding regulatory complexity, and limited team bandwidth. AI tools, when used correctly, directly address every one of these challenges. 

Attendees of this webinar will learn how to dramatically reduce the time spent on first drafts of SOPs, CAPA responses, labeling text, and regulatory correspondence. They will understand how to extract critical compliance requirements from lengthy FDA guidance documents in minutes rather than hours. They will gain the skills to use AI for predicate device research, submission section drafting, and Warning Letter response strategy — all while maintaining the expert oversight that a regulated environment demands. 

Beyond productivity, this webinar addresses compliance. FDA issued specific guidance on the use of AI in drug submissions in January 2025. The FDA and EMA jointly published AI Good Practice principles in January 2026. This session explains what those guidelines mean for your team, how to document AI use in your quality management system, how to protect confidential data, and how to catch AI errors before they become regulatory problems. 

Professionals who understand how to use AI responsibly in a regulated environment are more valuable, more efficient, and better positioned for the direction the industry is heading. This webinar gives you that understanding in 60 focused minutes. 

 Topics To Be Covered

The webinar will cover following topics. 

AI tools that are most relevant to FDA regulatory work — including ChatGPT, Claude, Microsoft Copilot, and specialized regulatory intelligence platforms — with an honest assessment of what each does well and where its limitations lie. 

AI-assisted document drafting, including SOPs, CAPA responses, labeling text, and sections of IND, NDA, and 510(k) submissions. A live demonstration will show the exact prompting technique and the expert review process used to validate the output. 

 How to use AI to analyze and decode FDA guidance documents — extracting compliance checklists, comparing revised versions, and surfacing the requirements most relevant to your product category. 

 FDA submissions and regulatory correspondence, including Pre-Submission question packages, deficiency letter responses, Warning Letter replies, and predicate device research support. 

Compliance, validation, and data privacy — covering FDA’s 2025 AI guidance, internal documentation requirements, hallucination risk management, and data security best practices for regulated environments. 

Five-step AI workflow that attendees can implement immediately, along with a prompt library and an AI-use SOP template provided as free downloadable resources. 

Who Will Benefit 

This webinar is designed for professionals working in any FDA-regulated industry. It is directly relevant to regulatory affairs managers and specialists, quality assurance and compliance professionals, regulatory consultants, regulatory writers, medical and clinical affairs teams, and senior leaders evaluating AI adoption for their organizations. It applies across pharmaceuticals, biotechnology, medical devices, dietary supplements, food, and cosmetics. Whether you are a practitioner looking to work smarter or a team leader building a compliant AI strategy, this session delivers immediate, actionable value.