Working with KT

CONDUCTING AND DOCUMENTING INVESTIGATIONS
The Next Step in Building GMP and Compliance

The Kepner-Tregoe (KT) 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.

DESCRIPTION
In this intensive work session, you will review KT’s acclaimed process approach to CAPA 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.

PREREQUISITE
Participants must have completed Problem Solving & Decision Making for Investigations and CAPAs or the standard Problem Solving & Decision Making workshop. Thiswork session benefits individuals and groups who areactively involved in efforts to find root cause and todocument investigations.

HOW YOU WILL BENEFIT
You will advance your skills in performing and documenting investigations by achieving these and other objectives:

• 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

To learn more or to request in-company training:
 

Public Workshop Schedule