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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Book Details

Format Paperback / Softback
ISBN-10 0367394766
ISBN-13 9780367394769
Publisher Taylor & Francis Ltd
Imprint CRC Press
Country of Manufacture GB
Country of Publication GB
Publication Date Oct 2nd, 2019
Print length 704 Pages
Weight 1,024 grams
Dimensions 15.30 x 23.10 x 3.90 cms
Ksh 12,750.00
Werezi Extended Catalogue 0 in stock

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This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.
A guidebook to FDA compliance, this text lists the necessary steps for meeting compliance requirements during the drug development process. Presenting comprehensive approaches for validating analytical methods for pharmaceutical applications, it covers important compliance and quality systems used in the FDA-regulated industries related to medical devices, pharmaceuticals, and biologics. The book includes topics such as validating analytical methods for pharmaceutical applications, stability testing, computer validation, vendor qualification, internal audit programs, and strategic planning for compliance and regulatory defensiveness.

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