CAPA in the Pharmaceutical and Biotech Industries - How to Implement an Effective Nine Step Program (Hardcover, New)

This book contains the most current information on how to implement, develop and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a 9-step closed-loop process approach for medical device, pharmaceutical and biologic manufacturers, as well as any company or institution, which has to maintain a quality system. CAPA violations along with ineffective complaint investigations continue to be the number one cited violation of device warning letters for the past four years, leading the US Food and Drug Administration or FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities. A review of FDA warning letters issued to pharmaceutical companies reveals that most of these warning letters resulted from recurring failures, ineffective investigations found, and missing or inappropriate corrective and preventive actions. Companies often make the mistake of fixing problems in their processes by revising procedures or more commonly by 'retraining' employees that may or may not have caused the problem. This is typically event-focused. Companies then will make the false assumption that the errors have been eradicated. In many cases they will also consider the steps taken as their Preventive Action. The reality is that the causes of the failure were never actually determined; therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach. It is a process and has to be understood throughout organizations. This book addresses all of the above issues, in a pragmatic, down- to-earth manner.

General

Imprint:	Woodhead Publishing Ltd
Country of origin:	United Kingdom
Series:	Woodhead Publishing Series in Biomedicine
Release date:	December 2015
First published:	March 2015
Authors:	J Rodriguez
Dimensions:	229 x 152 x 19mm (L x W x T)
Format:	Hardcover
Pages:	248
Edition:	New
ISBN-13:	978-1-907568-58-9
Categories:	Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Hi-tech manufacturing industries Books > Science & Mathematics > Biology, life sciences > Life sciences: general issues > General Books > Professional & Technical > Biochemical engineering > Biotechnology > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology Books > Law > Laws of other jurisdictions & general law > Private, property, family law > Personal property law > Intellectual property, copyright & patents
LSN:	1-907568-58-1
Barcode:	9781907568589

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