£29.69

CRC Press Preparing for FDA Pre-Approval Inspections 2nd Ed

Name: CRC Press Preparing for FDA Pre-Approval Inspections 2nd Ed
Brand: CRC Press
Price: 35.68 GBP
Availability: InStock

Pharmacology

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Description

Achieve regulatory success with the second edition of Preparing for FDA Pre-Approval Inspections. This essential guide helps organizations navigate the complexities of the inspection process to gain rapid regulatory approval. It addresses the major shifts in inspection activity, moving toward a systems-based approach that reflects modern regulatory environments. This updated edition takes into account current trends in FDA expectations and inspection activities. It covers modern regulatory frameworks such as the GMPs of the 21st Century and quality systems-based approaches. Readers will find detailed information on risk-based inspections, quality by design, process analytical technology, and design space. Whether you are managing pharmaceutical sciences or compliance teams, this book provides the necessary knowledge to meet current FDA standards and prepare your organization for successful inspections.

Key Features

Covers current FDA expectations including GMPs of the 21st Century and quality systems-based inspection approaches.

Provides guidance on modern regulatory concepts like quality by design and design space for pharmaceutical success.

Explains risk-based inspection activities to help organizations prepare for modern regulatory scrutiny.

Includes information on process analytical technology to support rapid regulatory approval goals.

Chronicles the major shifts in inspection activity to help teams adapt to new regulatory environments.

Product Specifications

Brand: CRC Press
Format: Hardcover
ASIN: 0849391849
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Other Branches of Medicine > Pharmacology
Domain: Amazon UK
Release Date: 05 March 2008
Listed Since: 30 December 2006

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CRC Press Preparing for FDA Pre-Approval Inspections 2nd Ed

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