Are your investigations done haphazardly or in an inconsistent manner? Are your reports hard to understand? Is the discrepancy resolution process slowing your product release efforts unnecessarily?

In this CAPA training you will learn how to document unexpected situations accurately and completely. We will also focus on corrective actions that are effective and thorough, thereby ensuring that the situation doesn’t repeat itself. While the FDA understands that things don’t always go according to plan, they fully expect you to have an effective program that resolves all issues and eliminates the possibility of recurrence. For practical exercise, we will examine specific FDA warning letters that highlight deficiencies other companies have faced.