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Author:   J Rodriguez (President, Monarch Quality Systems Solution, USA)
Publisher:   Elsevier Science & Technology
Imprint:   Woodhead Publishing Ltd
Volume:   No. 33
Dimensions:   Width: 15.20cm , Height: 1.80cm , Length: 22.90cm
Weight:   0.390kg
ISBN:  

9781907568589

ISBN 10:   1907568581
Pages:   248
Publication Date:   11 December 2015
Audience:   Professional and scholarly ,  College/higher education ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

Step-by-step basics on how to build a comprehensive CAPA program How to use a nine step CAPA process to effectively handle any product or quality system failures How to effectively use failure investigations and CAPA in order to handle, and process complaints investigations in a timely manner How to effectively use risk management concepts to assign a risk level to failure investigations in order to prioritize based on risk How to use Failure Mode and Effect Analysis to identify potential failure modes How to review data from post production, and post market in order to determine the need for changes as well as new mitigations activities Responding effectively to non-conformances, failures, deviations and complaints by identifying root causes and implementing corrective and preventative actions Efficient use of root cause analysis tools Optimizing CAPA and RCA documentation procedures Essential SOPs and other documentation Review areas of common FDA’s 483 inspection observations How to effectively identify and track deviations and non-conformances Learning to analyze and trend data to identify existing and potential causes of non-conformance Gathering, organizing and managing the correct data required to conduct an effective Root Cause Investigation Review the elements of a good investigation Integrating RCA and CAPA with other systems such as: Internal auditing, deviations, Out Of Specification (OOS) and complaint handling Performing trend analysis and using effective RCA tools How to use of statistical methodologies when performing Root Cause Analysis CAPA and the linkage to effective management review and annual product reviews Step-by-step basics on how to build your own comprehensive CAPA program Most important: Review of the real benefits of an effective CAPA system

Reviews

.. .useful for anyone working in quality assurance or regulatory affairs as a reference guide and as a tool for setting up or improving CAPA programmes. --<b>The Pharmacetical Journal, <i>CAPA in the Pharmaceutical and Biotech Industries</i></b>

Author Information

Jackelyn Rodriguez has over 28 years of experience that cover all facets of quality assurance and regulatory compliance. 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 consulting activities place emphasis on all aspects of regulatory compliance, training, Mock FDA audits/assessments, regulatory affairs and various FDA-related activities. Ms Rodriguez has published numerous compliance-related articles and has been a global industry speaker and presenter on several compliance topics. 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.

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