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CAPA for the FDA-Regulated Industry

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Title: CAPA for the FDA-Regulated Industry
Author: Jose Rodriguez-Perez
ISBN: 8174890440 / 9788174890443
Format: Hard Cover
Pages: 168
Publisher: ASQ/Infotech
Year: 2016
Availability: In Stock
Special Indian Edition Priced at Rs. 1095/-. FREE Shipping with in India.
     
 
  • Description
  • Contents

Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries.

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.

List of Figures and Tables
Preface

Chapter 1 : The Quality System and CAPA
Chapter 2 : CAPA and the Life Sciences Regulated Industry
Chapter 3 : Effective CAPA Process : From Problem Detection of Effectiveness Check
Chapter 4 : Documenting CAPA
Chapter 5 : The Ten Biggest Opportunities of the CAPA System and How to Fix Them
Chapter 6 : Developing an Internal CAPA Expert Certification
Chapter 7 : CAPA Forms
Chapter 8 : CAPA Final Recommendations

Appendix A
Acronyms
Glossary
Bibliography
Index

 
 
 
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