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Working with KT
Problem Solving & Decision Making for Investigations & CAPAs
Accelerate and Improve Investigations and CAPAs
KT'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.
In this three-day workshop, you will learn 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 risk and recognize opportunities for ongoing improvement. Using our FDA-recognized,
step-by-step approach, learn to close out these issues with complete and well-written investigations.
Using the KT approach in investigations will dramatically reduce the cycle time for approval and the number
of open investigations.
Use the acclaimed KT processes to address the deviations affecting compliance, production, and quality issues:
WHO SHOULD ATTEND: Anyone involved with writing, approving, or providing input to investigations in the areas of quality assurance, quality control, regulatory, audit, compliance or manufacturing in an FDA-regulated environment.
HOW YOU WILL BENEFIT: 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
Writing investigations that demonstrate structured thinking
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