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

Available as:

  • In-house class
  • Virtual
  • In-Person

Duration/days:

3

Languages:

DE
EN
FR
NL

Essentials

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.

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
  • Certification Credits : 2.1 CEUs
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In this county services are provided by the official KT licensee.

* Before applicable taxes

Class seats guaranteed with payment. Seat reservations held for 72 hours.

Contact us to inquire for more details or have the workshop customized upon your corporate needs.

  • 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
  • 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
  • Quotes

    “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

  • Brochure

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