CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program (Woodhead Publishing Series in Biomedicine)
| Author | : | |
| Rating | : | 4.31 (700 Votes) |
| Asin | : | 1907568581 |
| Format Type | : | paperback |
| Number of Pages | : | 248 Pages |
| Publish Date | : | 2014-06-25 |
| Language | : | English |
DESCRIPTION:
It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detailProvides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately. CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program 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 nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising pr
About the AuthorJackelyn Rodriguez has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry. Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. . Ms Rodriguez is the President of Monarch Quality Systems Solutions, a consulting firm serving in the technical and regulatory compliance capacity for several Pharmaceutical, Biologics and Medical Device manufacturers. Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. Her consulting activities place emphasis on all asp
"Five Stars" according to Terry Edwards. Wonderful source for quality inspectors
Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide. She has worked closely with CDRH’s FDA HACCP team for both promotion of Risk Management, training of over 1000 individuals, and worked with the FDA in their pilot study created to introduce the new Hazardous Analysis and Critical Control Points (HACCP) Inspection Technique to the Medical Device Industry. . J