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Free eBook- CAPA in the Pharmaceutical and Biotech Industries

Updated: May 27, 2022

According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence".

Corrective and Preventive Action procedures require analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned products, and other sources of quality data to identify existing and potential causes of a nonconforming product or other quality problems.

I found the below PDF available on LinkedIn while surfing and found it useful.

Thought it would be really helpful for all Quality Assurance and Regulatory Audit Professionals and specifically those who are accountable for taking major decisions.

Below PDF document that will help you to understand 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.

Click the PDF below and understand CAPA by the nine-step process approach...

CAPA in the Pharmaceutical and Biotech Industries
Download PDF • 3.71MB

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