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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Hardcover

Medical ReferenceChemistry

ISBN10: 0824740785
ISBN13: 9780824740788
Publisher: Crc Pr Inc
Published: Dec 9 2003
Pages: 694
Weight: 2.26
Height: 1.44 Width: 6.26 Depth: 9.12
Language: English
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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Chemistry