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Laboratory Audits: Building a Quality and Compliance Laboratory
Paperback
Series: Understanding the Life Sciences Industry
Publisher: Independently Published
Published: May 26 2025
Pages: 94
Weight: 0.30
Height: 0.19 Width: 6.00 Depth: 9.00
Language: English
This book is a practical, structured guide to understanding, preparing, executing, and responding effectively to laboratory audits. From the fundamentals of an audit to strategies for managing findings, you'll learn how to strengthen your quality system, prevent observations, and confidently lead each audit. You will learn how to
✅ Prepare your team and documentation for internal and external audits.
✅ Apply the ALCOA+ principle to ensure data integrity.
✅ Respond to observations and manage CAPAs effectively.
✅ Pass audits by regulatory agencies such as the FDA successfully. This book is an essential tool for analysts, supervisors, quality managers, and auditors who want to raise the compliance level in their laboratories.
Transform audits into an opportunity for improvement and strengthen quality in your laboratory.
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