---
title: "Annex 1 in Practice: Field-Tested Answers for Today's Implementation Challenges"
description: "This webinar moves beyond regulatory theory into execution, tackling the real implementation challenges sterile manufacturing teams are facing today, built on field-tested industry feedback."
url: https://qbdgroup.com/en/webinars/annex-1-in-practice-field-tested-answers-implementation-challenges
type: "Webinar"
language: en
published: 2026-09-16
category: "Qualification & Validation"
publisher: "QbD Group"
citation: "QbD Group, \"Annex 1 in Practice: Field-Tested Answers for Today's Implementation Challenges\", https://qbdgroup.com/en/webinars/annex-1-in-practice-field-tested-answers-implementation-challenges"
---
# Annex 1 in Practice: Field-Tested Answers for Today's Implementation Challenges
> This webinar moves beyond regulatory theory into execution, tackling the real implementation challenges sterile manufacturing teams are facing today, built on field-tested industry feedback.

This session is built directly on structured feedback gathered from pharmaceutical manufacturing professionals on where they need more practical depth. Rather than reintroducing Annex 1 concepts, our experts go straight into execution, focusing on the areas that matter most in day-to-day implementation.

Annex 1 implementation does not stop at the initial risk assessment or the first CCS draft. It lives in the ongoing decisions manufacturing and quality teams make every day: how often to revisit the CCS, how to approach single-use components without losing control over contamination risk, and which filter or monitoring strategy actually fits a given zone classification.

This webinar walks through these areas in full, so attendees leave with a complete, practical picture rather than a single recommendation.

## Agenda

**Live presentation + Q&A, with live chat and polls**

## What You'll Learn

- How to define and defend a CCS review cadence, ownership model and update triggers that hold up under inspection
- How to approach single-use components under Annex 1 without compromising contamination control
- What to check before, during, and after implementation to keep a single-use setup inspection-ready
- The full range of approaches to filter strategy and zone monitoring, including PUPSIT with multiple filters and tightened LAF/GAAS/Grade A monitoring, and how to weigh them for your facility
- How manufacturing peers across the industry are approaching these same decisions today

## Speakers

Two QbD Group qualification and validation experts bring hands-on Annex 1 remediation experience from sterile manufacturing sites across Europe.

### Jo Doucet

Global Head Qualification & Validation

**Qualification & Validation, QbD Group**

Jo 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.

### Stan Van Kerkhoven

Senior Project Manager Qualification & Validation

**Qualification & Validation, QbD Group**

Stan is a Senior Project Manager at QbD Group, leading Annex 1 gap assessments, contamination control strategy programs and cleanroom qualification projects for sterile manufacturing sites.

## Who Should Attend

This session is built for manufacturing, quality and engineering teams responsible for translating Annex 1 requirements into daily practice.

- **Site Heads and Plant Managers** accountable for sterile manufacturing compliance
- **Heads of Manufacturing and Operations Directors** driving remediation planning and execution
- **Quality Directors and QA Managers** owning the contamination control strategy
- **Engineering, Validation and Technical Operations Leads** designing filter and monitoring strategies
- **Cross-functional teams** responsible for CCS, remediation planning and execution
---
Source: https://qbdgroup.com/en/webinars/annex-1-in-practice-field-tested-answers-implementation-challenges — © QbD Group. Quote freely with attribution and a link back.