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Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Carmen Medina

353,83 €
IVA incluido
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Editorial:
Taylor & Francis Ltd
Año de edición:
2003
Materia
Química
ISBN:
9780824740788

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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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