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Problem Solving & Decision Making for CAPA (Corrective And Preventive Actions)

  • In-Person or Virtual
  • DE EN FR

Overview

Problem Solving & Decision Making for Corrective and Preventive Actions (CAPAs) is an FDA-recognized, step-by-step approach to close out deviations with complete, well-documented investigations. Through this workshop, you’ll learn how to respond to deviations with a process that is focused, rapid, and fully documented. Ideal for pharmaceutical and medical device companies, Problem Solving & Decision Making for CAPAs provides the essential framework for satisfying agency investigation requirements and eliminating future deviations.

Course details

What's Included

What You Get:

  • 3 days led by an expert instructor
  • Access to digital tools and resources
  • Skills and approaches for satisfying agency investigation requirements and eliminating future deviations
  • Certificate of completion & KT Foundation Badge
  • Certification Credits : 2.1 CEUs

Audience

Anyone who has to investigate, find root cause, manage investigations or CAPAs. This includes operators who support investigations through to managers who approve investigations.

Benefits

  • Learn root cause analysis to cut through the complexity of pharmaceutical and bio-pharmaceutical manufacturing, confidently respond to warning letters, satisfy auditors, and avoid future issues
  • Establish a systematic approach to classify and prioritize investigations, find cause, choose the most effective and efficient corrective and preventive actions to maintain compliance and improve throughput
  • Reduce cycle time for investigation approval and the number of open investigations
  • Incorporate risk analysis into decision making to avoid future problems and leverage opportunities for improvement

Skills Developed

  • Take corrective and preventive actions by using a structured troubleshooting approach
  • Use logic and data to systematically find and confirm true and root causes
  • Reduce the cost of investigations by increasing the efficacy and speed of CAPAs
  • Use incisive, easy-to-learn and apply questioning techniques
  • Focus on accurate results even when tensions are high and costs are rising
  • Improve transparency with structured thinking and clear communications

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