Investigations and Corrective/Preventive Actions

In this seminar, you will learn how to document unexpected situations accurately and completely. 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 seminar, 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.

Areas Covered in the seminar:

• How to gather information quickly and efficiently.
• How to initiate an investigation.
• Determine which information is relevant.
• Eliminate unnecessary/irrelevant information.
• How to determine the most probably cause of an event.
• Create a corrective action plan that is effective.
• Ensure CAPAs do not cause further damage.

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Manufacturing and operations personnel
• QA managers and personnel
• Quality control personnel
• Facility maintenance and calibration personnel
• Logistics and supply personnel