---
title: "Annex 1 in Practice: Field-Tested Answers on CCS Governance, First Air Risk and Filter Strategy"
description: "This webinar moves beyond regulatory theory into execution, addressing three areas where sterile manufacturing teams most often struggle to translate Annex 1 requirements into day-to-day practice. Learn how to keep your CCS **audit-ready**, apply **first air risk assessment** to real scenarios, and navigate the **filter strategy and zone monitoring** decisions your facility is likely facing right now."
url: https://qbdgroup.com/en/webinars/annex-1-in-practice-ccs-governance-first-air-risk-filter-strategy
type: "Webinar"
language: en
published: 2026-09-16
category: "Qualification & Validation"
publisher: "QbD Group"
citation: "QbD Group, \"Annex 1 in Practice: Field-Tested Answers on CCS Governance, First Air Risk and Filter Strategy\", https://qbdgroup.com/en/webinars/annex-1-in-practice-ccs-governance-first-air-risk-filter-strategy"
---
# Annex 1 in Practice: Field-Tested Answers on CCS Governance, First Air Risk and Filter Strategy
> This webinar moves beyond regulatory theory into execution, addressing three areas where sterile manufacturing teams most often struggle to translate Annex 1 requirements into day-to-day practice. Learn how to keep your CCS **audit-ready**, apply **first air risk assessment** to real scenarios, and navigate the **filter strategy and zone monitoring** decisions your facility is likely facing right now.

_This webinar moves beyond regulatory theory into execution, addressing three areas where sterile manufacturing teams most often struggle to translate Annex 1 requirements into day-to-day practice. Learn how to keep your CCS **audit-ready**, apply **first air risk assessment** to real scenarios, and navigate the **filter strategy and zone monitoring** decisions your facility is likely facing right now._

🕐 3 PM CET

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 defend a first air risk assessment during an inspection, and which filter or monitoring strategy actually fits a given zone classification.

This webinar walks through each of these three 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 apply a first air / smoke study risk assessment tool to real manufacturing scenarios, step by step
- What separates a defensible risk assessment from a theoretical one
- 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
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Source: https://qbdgroup.com/en/webinars/annex-1-in-practice-ccs-governance-first-air-risk-filter-strategy — © QbD Group. Quote freely with attribution and a link back.