Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

Name: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Brand: CRC Press
Availability: OutOfStock
Rating: 5 (1 reviews)

By Carmen Medina

0 - Default Title

Description

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.

Product details

Binding:: Paperback
Edition:: 1
Number of Pages:: 696
Release Date:: 2019-09-27
Publication Date:: 2019-10-02
Publisher:: CRC Press
Languages:: Original: English
ISBN10:: 0367394766
ISBN13:: 9780367394769
GPSR Manufacturer Reference:: [email protected]
Weight:: 991 g
Height:: 152 cm
Width:: 229 cm
Thickness:: 37 cm

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