QA Manager Operational Guide – Deviation, CAPA, and Audit Readiness
QA Manager Operational Guide – Deviation, CAPA, and Audit Readiness
Become more effective in your role as a QA Manager / QA Officer with the GuideGxP Operational Guide.
A comprehensive manual that translates regulatory requirements (EU GMP Annex 15 and EMA/FDA guidelines) into practical tools for daily quality management.
What you’ll find inside:
✅ Deviation and CAPA management explained step by step
🔍 Audit readiness: how to prepare for inspections without stress
📑 Integrated templates for investigations and follow-ups
🚀 Common mistakes to avoid + real inspection cases
This guide isn’t academic theory — it’s designed to simplify the daily work of those managing processes, people, and documentation in QA.
Each chapter is enriched with checklists, practical examples, and operational boxes.
Format: Professional PDF
Length: 92 pages
Updated: 2025 – compliant with the latest EMA/EU GMP revisions
Available languages: ITA – ENG
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What will I find in this guide?
In addition to operational explanations of the relevant regulations, you will find checklists, templates, real-life cases, and common mistakes to avoid.
How up-to-date is the guide?
The guide includes updated references to the latest EMA and EU GMP regulations, as well as guidance from all international inspection bodies. In the event of future revisions, we expect updates to be made available to buyers.
How long is it and how long does it take to read?
Each guide has a specific length based on the complexity of the topic, but they are all designed for quick reference. You can use it as a daily reference manual.
Who is this guide most useful to?
Junior professionals → to learn quickly and reduce errors.
Senior professionals → to have ready-to-use checklists and templates to share with the team.
Can I download it multiple times or share it?
Once purchased, you can download and keep it. It is for personal or internal business use only, but external redistribution is not permitted.