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Online Course - 2 Hours

Course Overview:

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.  And real world examples and a checklist will be demonstrated to aid in the effective auditing of integrity practices.  Employees rarely choose to commit fraud in the laboratory and it is usually the lack of knowledge on proper record keeping or technique.  Education provides best practices and establishes expectations for the proper method of testing and reporting sample information.  Fraud can impact all industries.  This course will address data integrity and ethics in the laboratory.

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 Regulator Requirements
  • Laboratory Fraud
  • Laboratory Oversight and the Internal Audit
  • Prevention
  • Reporting Issues
  • Laboratory Employee Responsibility

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

Certificate of Attendance

  • All registered attendees receive a certificate of attendance

Who Should Attend:

Pharmaceutical, Environmental (TNI and QSM/DOD), Commercial, and Plant Managers.

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