Corrective Action Programs for Regulatory Environments

Respond with confidence

Kepner-Tregoe's systematic approach to handling and responding to regulatory issues, quality problems, validations, complaints and recalls is used by life science organizations worldwide to meet the challenges of operating in a regulated environment efficiently and economically.

Results delivered

• Problems solved saving a total cost of $500,000 for a bio-pharma manufacturer over a three month time-frame

 

Our Solution

Take control of your investigations and corrective actions

The Kepner-Tregoe solution is based on our acclaimed process approach to respond to deviations—an approach that is focused, rapid, and fully documented. Cut through the complexity of compliance by setting priorities, troubleshooting issues, and taking the most effective and efficient corrective and preventive actions. Learn to control risks and recognize opportunities for ongoing improvement. Using our FDA-recognized, step-by-step approach, learn to close out these issues with complete and well-documented investigations. Using the KT approach in investigations will dramatically reduce the cycle time for approval and the number of open investigations.

By using KT's standard, best-practice approach for every non-conformance, you will remarkably improve the quality of your investigations and reduce approval cycle time by:

• Assessing complex issues and breaking them down systematically to correctly create and support investigations

• Listing and prioritizing issues relevant to the investigation
• Using a logical and systematic process to find and confirm true and root causes
• Finding the true cause of a problem before investing in expensive corrections
• Accessing relevant information by using incisive questioning techniques
• Dealing rationally and constructively with emergency situations
• Demonstrate structured thinking when closing 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

Interested to maximize your Return On Investment?  Learn more about our Results Model

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