Conducting and Documenting Investigations

Meet your compliance goals

The Kepner-Tregoe approach to conducting and documenting investigations helps ensure compliance with FDA cGMP requirements. It is used in organizations worldwide to improve the quality and speed of completing investigations and satisfying FDA requirements for documentation.

Results delivered

• Reduce time to find root cause
• Decrease average time to closure
• Reduce outstanding investigations
• Reduce recurring problems
• Increase thoroughness of investigations
• Reduce audit findings and observations
• Reduce reviews and approval cycles and cycle times

 

Our Solution

Investigate completely, minimize recurrence

Though our approach, you will review KT’s acclaimed process approach to CAPA (Corrective and Preventive Action) and then build advanced skills in using KT Problem Analysis to find root cause. We will also review using Decision Analysis and Potential Problem Analysis to select appropriate corrective and preventive actions, and show how to integrate KT tools into Six Sigma and Lean methods to drive robust investigations. Then, you will learn effective technical writing principles to document your findings. By integrating a systematic approach to analysis into conducting and documenting investigations, you will improve compliance by eliminating recurring problems with appropriate CAPAs and streamlining the review process with well written investigations.

We build capability

Our goal is to build true capability within your people and organization. This is not achieved by skill development alone. Adoption is the driver of results. That’s why we work with you to maximize the ROI from your “people investment” by:

• Clarifying your capability development objectives and how they tie to your business success
• Identifying areas of emphasis for development and how the new skills will be applied inside your business
• Helping you identify critical elements in your company’s performance environment that support or hinder the capability development process
• Pre- and post-skill development support and coaching to ensure we maximize the skills transfer from the “workshop room” into the real world

Offered as a workshop. Go to our workshop section to see scheduled dates and locations.