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) using a nine-step, closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as anyone who has to maintain a quality system

J Rodriguez (Author)

9781907568589, Elsevier Science

Hardback, published 11 December 2015

248 pages
22.9 x 15.1 x 2.1 cm, 0.39 kg

"...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." --The Pharmacetical Journal

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 procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. 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. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.

• 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

Subject Areas: Pharmacy / dispensing [MQP]