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.

 **Update: This course is now closed for registration. To be notified on the next course opens click here

COURSE OVERVIEW

This highly participative course provides an overview of the new ISO/IEC 17025 standard. This course will explain the differences between ISO 17025:2017 and ISO 17025:2005. Practical workshops and case studies help students understand and apply the new requirements of the ISO 17025:2017 standard to their current Quality System. You will develop an understanding of how the new requirements will affect and improve your organization.

Learn the steps to take now to ensure a successful transition to ISO 17025:2017. This course also includes "Ask the Assessor" where students can gain valuable insight into what lead assessors and auditors are looking for and get practical real-world advice, best practices, and tips.

COURSE CONTENT

• High level explanation of the differences between ISO 17025:2017 and ISO 17025:2005
• Understanding the key elements and importance of a gap assessment
• Transition Planning
• Important Quality Management Updates
• Important Technical Requirements
• Ask the Assessor

Student Prerequisites: 

Each student shall be required to have studied the most newly revised draft version of ISO/IEC 17025:2017 prior to attending the course. 

Please bring a copy of the standard with you to the class in order to receive course materials.

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

• Gain insight and best practice advice and tips

WHO SHOULD ATTEND:

This course is acceptable for all laboratory staff who participate in the operation of the laboratory quality system including:

• Conducting testing or calibration
• Supporting laboratory activities
• Managing the laboratory quality system
• Training laboratory staff
• Managing the laboratory