---
title: "EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation"
description: "This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance."
url: https://qbdgroup.com/en/webinars/webinar-on-demand-eu-gmp-annex-1-implementation-regulatory-expectations-practical-remediation
type: "Webinar"
language: en
published: 2026-05-04
category: "Quality Assurance"
publisher: "QbD Group"
citation: "QbD Group, \"EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation\", https://qbdgroup.com/en/webinars/webinar-on-demand-eu-gmp-annex-1-implementation-regulatory-expectations-practical-remediation"
---
# EU GMP Annex 1 Implementation: From Regulatory Expectations to Practical Remediation
> This webinar translates the revised EU GMP Annex 1 requirements into structured, practical actions across sterile manufacturing environments. Learn how to assess implementation challenges, prioritize remediation efforts and strengthen sustainable compliance.

## About this webinar

The revised **EU GMP Annex 1** represents one of the most significant **regulatory updates for sterile manufacturing** in recent years. Beyond interpretation, authorities now expect demonstrable, **fact & risk-based** and **sustainable implementation** across facilities, utilities, quality systems and **contamination control strategies**. "Risk"-based arguments for not being compliant are not accepted anymore.

This webinar provides a structured approach to **Annex 1 readiness and remediation**. Our experts will explore the historical evolution of Annex 1, analyze the **practical challenges manufacturers face**, and focus on **critical remediation areas** frequently linked to **inspection findings**.

Drawing on **regulatory trends** and insights from **FDA warning letters**, the session connects regulatory expectations with real-world **implementation strategies** to support decision-making at site level.

## What you'll learn

- How Annex 1 evolved and why its implementation requires a **cross-functional, risk-based approach**
- How to identify and prioritize **remediation areas** based on inspection trends, time for implementation and operational risk
- What regulators expect in the **most critical implementation areas** under Annex 1
- What **FDA warning letters** reveal about Annex 1 readiness and recurring non-conformities
- How to structure a practical **remediation roadmap** aligned with sustainable compliance

## Speakers

This session brings together **decades of hands-on experience in sterile manufacturing, GMP compliance, and contamination control strategy**. Our speakers combine deep technical expertise with regulatory insight gained from global leadership roles at organizations including Alcon, Novartis, and Sandoz — offering practical guidance you can apply directly to your Annex 1 remediation journey.

### Jo Doucet
**Global Head Qualification & Validation, QbD Group**

Jo Doucet is an expert in qualification and validation with over 20 years of experience in the pharmaceutical industry. He leads the Qualification/Validation division at QbD Group, supporting teams and clients in GxP compliance projects across manufacturing, IT, QC, and medical devices.

### Geert Vandenbossche, PhD
**Founder & Owner, C&E Solutions**

Geert brings 30 years of senior leadership experience from Alcon/Novartis across both global and site roles. As Global Head of Engineering and MS&T, he successfully integrated the Advanced Accelerator Applications start-up into the Novartis Radioligand Therapy unit. Earlier, Geert served as Global Head of Quality for all Sandoz Sterile and for Novartis Biologic sites, leading Global Quality Strategic Initiatives with a key focus on Annex-1 aseptic processing.

## Who Should Attend

This webinar is ideal for professionals working in sterile manufacturing and GMP compliance.

- Site Heads and Plant Managers
- Heads of Manufacturing and Operations Directors
- Quality Directors and QA Managers
- Engineering, Validation and Technical Operations Leads
- Cross-functional teams responsible for CCS, remediation planning and execution
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Source: https://qbdgroup.com/en/webinars/webinar-on-demand-eu-gmp-annex-1-implementation-regulatory-expectations-practical-remediation — © QbD Group. Quote freely with attribution and a link back.