Description
Realistic scenarios and real world examples demonstrate how learners can detect and prevent practices that negatively impact data defensibility. This course meets requirements for TNI and QSM/DOD initial and annual data integrity training.
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. 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
- Definitions
- Data Integrity and Ethics Regulatory Requirements
- Improper Practice versus Laboratory Fraud
- Laboratory Oversight and the Internal Audit
- Prevention
- Reporting Issues
- Laboratory Employee Responsibility
Course Curriculum
- Introductions & Overview
- Definitions
- Scenarios
- Standards/Regulations
- Laboratory Data Examples
- Types of Fraud
- Ethical Issues Examples
- Red Flags
- Addressing Data Integrity
- Course Wrap-Up
- Course Completion Survey
Course pricing
$99 per student
Registering a group?
Get your group discount code and assistance with group registration.
Labtopia offers group training discounts for groups of 3 and more.
Who should attend?
Pharmaceutical (FDA regulated), environmental (TNI and QSM/DOD), commercial, lab managers and analysts, quality managers, and plant managers.
Certificate of Attendance
All attendees receive a certificate of attendance upon course completion.
All Labtopia trainers and consultants have technical backgrounds. Our co-founders have over 30 years’ experience in managing quality systems and directing bench activities in regulated environments.