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Type: BOOK - Published: 2014-08-15 - Publisher: Quality Press
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality syst
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Type: BOOK - Published: 2016-04-19 - Publisher: CRC Press
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutica
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Pages: 387
Type: BOOK - Published: 2019-02-04 - Publisher: CRC Press
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational
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FDA Regulations and Associated Guidance Documents: - Code of Federal Regulation Title 21 Overview - Part 11 Electronic Records; Electronic Signatures (21CFR§11