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.
Audience: Anyone who has to investigate, find root cause, manage investigations or CAPAs. This includes operators who support investigations through managers who approve investigations.
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.
Through this Kepner-Tregoe workshop, you will learn to take corrective and preventive actions by using a troubleshooting approach that:
- Uses logic and data to systematically find and confirm true and root causes.
- Reduces the cost of investigations by increasing the efficacy and speed of CAPAs.
- Uses incisive, easy-to-learn and apply questioning techniques.
- Focuses on accurate results even when tensions are high and costs are rising.
- Improves transparency with structured thinking and clear communications.
Return on Investment
- Reduce outstanding investigations.
- Increase accuracy of investigations.
- Avoid FDA 483s Warning Letters.
- Improved ratings on internal audits.
- Speed reviews/approvals.
- Reduce time to find root cause.
- Reduce recurring problems.
- Decrease average time to closure.
Duration: 3 days
Learning Tools Included: All workshop attendees will receive the Kepner-Tregoe Tablet App and access to online post-workshop learning support tools (coaching videos, tips, tricks and more) with a My KT membership
Certification Credits: 21 PDUs / 2.1 CEUs
Training Options: Available as a Public Session or as on-site group training at your location