Staying compliant means ensuring every aspect of your organization adheres to the right protocols—at the right time. Kepner-Tregoe’s Conducting and Documenting Investigations workshop provides the essential framework to conduct and document investigations to meet your compliance goals. Through Conducting and Documenting Investigations, you’ll learn and apply key approaches from Kepner-Tregoe’s proven Problem Analysis, Decision Analysis and Potential Problem Analysis frameworks to identify root cause and determine appropriate corrective and preventative actions.
Audience: Ideal for manufacturing quality managers, analysts, technicians, problem and incident managers, auditors, engineers, and others responsible for resolution of critical issues and managing organizational problems.
Specifically designed to ensure compliance with FDA cGMP requirements for pharmaceutical, medical device or other regulated manufacturers.
Improve the quality and speed of conducting investigations.
Complete documentation quickly and thoroughly with a structured, easy-to-learn approach.
Easily integrates with continuous improvement methods, including Lean and Six Sigma.
Through Kepner-Tregoe’s Conducting and Documenting Investigations workshop, you will develop the skills necessary to ensure successful compliance, including how to:
- Apply the Kepner-Tregoe process to Corrective and Preventive Actions (CAPAs).
- Evaluate problems to determine root cause and identify potential problems.
- Learn how to easily integrate KT tools with Lean and Six Sigma initiatives to drive investigations.
- Develop effective technical writing skills to document findings.
- Streamline the review process with well-documented investigations.
Return on Investment
- Reduce average time to closure.
- Limit the number of outstanding investigations.
- Avoid recurring problems.
- Streamline audit findings and observations.
- Improve review and approval cycles and cycle times.
Duration: 3 days
Certification Credits: 2.1 CEUs / 21 PDUs
Training Options: Explore the class schedule below to register for a Public Session workshop or contact us to bring this workshop on-site to your organization.