A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies
A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies
The role of the Validation & Calibration Expert is to ensure that facilities, instruments, and processes are qualified, calibrated, and validated in accordance with international standards.
This operational guide walks you through ISO 17025 and the DQ/IQ/OQ/PQ qualification requirements, providing practical tools to face audits and maintain compliance.
What you’ll find inside:
🔬 ISO 17025 explained clearly and applicable to day-to-day operations
📊 DQ/IQ/OQ/PQ qualifications presented step-by-step with real examples
✅ Checklists for process and method validation
🚀 Common audit findings and how to effectively defend your position
Each section is enriched with diagrams, operational tables, and real case studies to minimize the risk of non-compliance.
A complete manual designed for professionals in Technical QA, Validation, and Maintenance, who need clear, concrete references to manage complex activities.
Format: Professional PDF
Length: 186 operational pages
Updated: 2025 – includes references to the latest ISO and EU GMP revisions
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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.