CAPA in the Pharmaceutical and Biotech Industries
How to Implement an Effective Nine Step Program
This book 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 device, pharmaceutical, and biologic manufacturers, as well as any company or institution that has to maintain a quality system.
This book covers following content:
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)
7. Step 4: data gathering and analysis
8. Step 5: investigation
9. Step 6: part I—root cause analysis
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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