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

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

• 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

• 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

“Reinforcing the communication and follow-up on who-does-what has led to better communication and less falling through the cracks. In our matrix organization, this is rather critical.”

— Group Project Manager, Life Sciences

 

“KT PSDM CAPA provides a common approach and logical process to develop corrective action and preventive action.”

– Assisant QC Manager

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