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Friday, August 2 2019

Wednesday, May 29, 2019 midnight
Multi-day Event
Online Courses

Online Course - 2 Hours

Course Overview:

Enjoy this webinar on your own time at your own pace!

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.

 

8:30 AM - 4:30 PM
Thursday, Aug 1, 2019 8:30 a.m.
Multi-day Event
Labtopia Classroom Courses

ISO 17025:2017 INTERNAL AUDITOR TRAINING

 

Course Overview:

This highly participative course provides comprehensive instruction on auditing management and technical requirements based on the ISO 17025:2017. Through practical workshops, case studies, and simulated assessments you will develop an understanding of how the new requirements will affect your organization and your audits. The training will teach process-based audit skills, which are useful in internal and external audits. Additionally, by using real-world audit situations, you will practice your auditing skills and techniques to help you fully understand the requirements of auditing to the ISO 17025:2017 standard.  

Student Prerequisites

Each student must have working knowledge of ISO 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.

Key Session Topics:

  • Management System Requirements Overview – This class will be taught based on assessing the requirements in Option A. 
  • The Audit Program and Team
  • Audit Types & Techniques
  • Four Phases of the Audit Process
  • Methods for improving communication skills
  • Constructing an audit program and the use of audit checklists
  • Writing effective corrective actions
  • Reporting audit findings and conclusions
  • Overview of ISO 17025:2017 Technical Requirements (Sections 4 through 7)
  • Auditing technical methods

Question & Answer Time "Ask the Assesor"

  • Gain insight and best practice advice and tips

Who Should Attend?

Those responsible for planning and scheduling an internal audit program for ISO 17025, those who must perform audits to ISO 17025, quality assurance managers, quality assurance professionals, ISO project managers and team members.  This course is also 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.