CAPA in the Pharmaceutical and Biotech Industries How to Implement an Effective Nine Step Program 1st Edition Rodriguez 1908818379 9781907568589 9781908818379

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Product details:

• ISBN-10: 1908818379
• ISBN-13: 9781907568589, 9781908818379 
• Author: J Rodriguez

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.

Table of contents:

1. Understanding the FDA’s CAPA requirements and regulations
2. Implementing a CAPA program: Going back to basics
3. The nine-step CAPA program
4. Step 1: identification of the event and writing a proper problem statement
5. Step 2: risk assessment and impact assessment
6. Step 3: evaluate event and initiate remedial actions (correction)
Part I. Internal corrections
Part II. Corrections and removals (external corrections)
7. Step 4: data gathering and analysis
8. Step 5: investigation
9. Step 6: part I—root cause analysis
Part III: example of investigation tools for why diagrams and fault tree diagrams
10. Step 7: corrective and preventive action plans
11. Step 8: implement and follow-up on action plans
12. Step 9: verification of effectiveness
13. Examples of procedures

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