Investigations and Corrective/Preventive Actions

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

Instructor Profile:

Nick Campbell, is the founder of Sunriver Risk Management, a consulting firm that specializes in compliance training for the bioscience industry. He has spent his 20-year career working in operations for highly regulated industries, including the last 15 years in the pharmaceutical, medical device, and biotechnology sectors. His skills include a high level of proficiency in process engineering and facility operations. He has been instrumental in numerous regulatory audits including FDA, European Union, and Health Canada.

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