---
title: "Regulatory Evolution: What AI Means for GMP Manufacturing"
description: "A practical, inspector-informed look at what deploying AI in GMP-regulated environments really means: validation, human oversight, auditability, explainability, and the ongoing monitoring that traditional CSV was never designed for."
url: https://qbdgroup.com/en/webinars/regulatory-evolution-what-ai-means-for-gmp-manufacturing
type: "Webinar"
language: en
published: 2026-07-08
category: "Software Solutions & Services"
publisher: "QbD Group"
citation: "QbD Group, \"Regulatory Evolution: What AI Means for GMP Manufacturing\", https://qbdgroup.com/en/webinars/regulatory-evolution-what-ai-means-for-gmp-manufacturing"
---
# Regulatory Evolution: What AI Means for GMP Manufacturing
> A practical, inspector-informed look at what deploying AI in GMP-regulated environments really means: validation, human oversight, auditability, explainability, and the ongoing monitoring that traditional CSV was never designed for.

AI is moving from proof of concept into **GMP-regulated manufacturing**, and inspectors have noticed. Recent sessions with the **FDA and UK MHRA** have flagged the same pitfalls again and again: models that drift once deployed, unclear human oversight, and validation approaches built for static computerized systems being stretched to cover something they were never designed for.

This webinar cuts past the theoretical AI hype and focuses on **what deploying an AI system in a GMP environment actually looks like in practice** — what inspectors are currently examining, why AI needs deeper ongoing monitoring than traditional computerized systems, and the reminder that existing GMP requirements (user access, audit trails, change control) still fully apply to AI-enabled tools.

You do not need to be an AI expert to attend. If you own quality, validation, or regulatory compliance in a pharma or biotech manufacturing site, this session gives you a **practical framework** to prepare for the next wave of AI-related inspection findings.

## Agenda

**45 minutes presentation + 15 minutes live Q&A**

- **Why AI is becoming a regulatory topic** — adoption trends across pharma manufacturing and why inspectors are paying attention now
- **AI use cases entering regulated environments** — deviation investigations, document review, knowledge assistants, process monitoring
- **Key compliance questions** — validation, human oversight, auditability, and explainability
- **How AI may change CSV/CSA approaches** — risk-based validation, continuous improvement challenges, and managing model changes
- **Practical roadmap** — what manufacturers should start doing now to stay ahead of inspection expectations

## What You'll Learn

- What FDA and MHRA inspectors are currently looking at when AI shows up in a GMP environment
- Why AI systems require deeper, continuous monitoring compared with traditional computerized systems
- How to apply existing GMP requirements (user access, audit trails, change control, data integrity) to AI-enabled tools
- How risk-based validation (CSV / CSA) needs to evolve to handle model drift, bias, and continuous improvement

## Speakers

Two QbD experts working at the intersection of digitalization, computerized systems, and GMP compliance.

### Jan Appelmans

**Senior Consultant Software Services, QbD Group**

Jan supports pharma and biotech manufacturers on computerized system validation, digitalization projects, and the compliance implications of new technologies — including AI — entering GMP environments.

### Elias Muys

**Associate Consultant, QbD Group**

Elias has a background in bioscience engineering and an advanced master in AI as well as with hands-on experience in pharmaceutical qualification and validation. He explores practical ways to use AI and automation to streamline everyday tasks while keeping the requirements of regulated environments in mind.

## Who Should Attend

This webinar is built for pharma and biotech manufacturing organizations preparing for AI in GMP environments — no prior AI expertise required.

- **Heads of Manufacturing** who need a clear view of AI-related regulatory risk and readiness
- **Qualified Persons (QP), Quality Directors and QA leads** responsible for release, oversight, and audit readiness
- **Validation and CSV / CSA leads** owning risk-based validation of computerized and AI-enabled systems
- **Regulatory Affairs and Compliance managers** tracking evolving FDA, EMA and MHRA expectations on AI
- **Digital transformation and Manufacturing IT leads** deploying AI use cases across GMP sites
---
Source: https://qbdgroup.com/en/webinars/regulatory-evolution-what-ai-means-for-gmp-manufacturing — © QbD Group. Quote freely with attribution and a link back.