Defensibility of data is a key issue in the laboratory. Laboratories reporting data for regulatory bodies are required to train employees in data integrity and ethics to ensure that proper laboratory technique is used for generating data. The training will cover common indicators for laboratory fraud and how the supervisor or data reviewer can develop a program to ensure data generated in their laboratory is defensible and complete. An in-depth internal auditing program is important to discover and rectify any evidence of laboratory fraud. Real world examples are discussed to determine if there are any “Red Flags”. Education provides best practices and establishes expectations for the proper method of testing and reporting sample information. This course will address data integrity and ethics in the laboratory as fraud can impact all industries.
This class will meet the requirements for initial and annual employee Data Integrity training for TNI and QSM/DOD.
Definitions
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Scenarios
Standards/Regulations
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Laboratory Data Examples
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Types of Fraud
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Jeanné Mensingh, Labtopia co-founder, is a Senior Consultant and Instructor for Labtopia Solutions and Labtopia Training. She has extensive experience in regulated industries and all aspects of laboratory operation, from the analytical bench, QA management, plant operations, and commercial laboratory environments.
A natural storyteller, Jeanné has a gift for retaining the interest of her learners, notably when sharing her true life experiences from the laboratory trenches.
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