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.
Key Session Topics:
- Data Integrity and Ethics Regulatory Requirements
- Improper Practice versus Laboratory Fraud
- Laboratory Oversight and the Internal Audit
- Reporting Issues
- Laboratory Employee Responsibility
Certificate of Attendance
- All paid attendees who complete the training and satisfy the course quiz requirements will receive a certificate of attendance
Who Should Attend:
Pharmaceutical (FDA Regulated Industry), Environmental (TNI and QSM/DOD), Commercial, lab analysts, lab managers, quality managers, and plant managers.
Gain insight and best practice advice and tips from a certified assessor!
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