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Analytical Instrument Qualification and System Validation
Abstract:
This 60-page primer explains how to successfully qualify analytical instruments according to regulations and quality standards. It includes concept, examples, templates and recommended procedures based on the 20 years of multinational experience and knowledge of its author Ludwig Huber, chief advisor for global FDA compliance.
Keywords:
qualification, compliance, USP 1058, regulations, FDA, GLP, 21 CFR Part 11
Publication Number:
5990-3288EN
Last Updated:
1/27/2009
Number of Pages:
60
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(1.34 MB)