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Thursday, October 3 2024

8 AM - 5 PM
Monday, Jan 1, 2024 8 a.m.
Multi-day Event
Online Courses

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 

  1. Introductions & Overview
  2. Definitions
  3. Scenarios
  4. Standards/Regulations
  5. Laboratory Data Examples
  6. Types of Fraud
  7. Ethical Issues Examples
  8. Red Flags
  9. Addressing Data Integrity
  10. Course Wrap-Up
  11. Course Completion Survey

More

Course pricing

$99 per student

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Registering a group?

Get your group discount code and assistance with group registration.

Labtopia offers group training discounts for groups of 3 and more.

After submitting, if you do not receive your group discount code check your junk and spam folders. If you still do not receive your group discount code email aelmore@labtopiainc.com

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.

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8 AM - 5 PM
Monday, Jan 1, 2024 8 a.m.
Multi-day Event
Online Courses

This course provides a complete overview of the ISO/IEC 17025 standard. It explains how the standard’s requirements affect and improve organizations. Learners will benefit from immediately applicable insights, advice, best practices, and tips.

Course Overview

This highly participative course provides an overview of the ISO/IEC 17025 standard and includes all aspects of the standard. Through practical case studies you will develop an understanding of how the requirements of the standard affect and improve your organization. This course also includes "Ask the Assessor" where students can gain valuable insight and get practical real-world advice, best practices, and tips. 

Key Session Topics

  • Understanding the elements of ISO 17025 (all sections included)

  • Maintenance and Calibration Plans

  • Original vs Amended/Corrected Data

  • Amendments and CoAs

  • Measurement of Uncertainty - Decision Rule

  • Method Validation vs Verification

Course Curriculum 

  1. Introductions & Learning Objectives
  2. ISO 17025 Structure
  3. General Requirements
  4. Structural Requirements
  5. Resource Requirements
  6. Process Requirements
  7. Management System Requirements
  8. Course Wrap-Up
  9. Course Completion Survey

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ISO 17025 Overview Training Course

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Registering a group?

Get your group discount code and assistance with group registration.

Labtopia offers group training discounts for groups of 3 and more.

After submitting, if you do not receive your group discount code check your junk and spam folders. If you still do not receive your group discount code email aelmore@labtopiainc.com

 

Who should attend?

Quality assurance personnel, laboratory management, laboratory staff, and ISO 17025 implementers.

Certificate of Attendance

All attendees receive a certificate of attendance upon course completion.

Discover your potential, starting today

Enroll today

8 AM - 5 PM
Monday, Jan 1, 2024 8 a.m.
Multi-day Event
Online Courses

An invaluable resource when considering ISO 17025 accreditation, this course provides a step-by-step roadmap for successful implementation and delivers critical insights for the development of an effective execution plan.

Course Overview

This course provides critical insights for the development of an effective execution plan, outlining what tasks must be accomplished and when. It highlights the resources necessary to navigate the accreditation journey and provides a basis for a realistic, achievable timeline. 

Key Session Topics

  • Grasp the scope of the administrative and practical requirements associated with ISO 17025 accreditation

  • Form a general impression of the time necessary to achieve accreditation

  • Navigating the accreditation journey

Course Curriculum 

  1. Introductions & Learning Objectives
  2. ISO 17025 Roadmap (Part 1)
  3. ISO 17025 Roadmap (Part 2)
  4. Course Wrap-Up
  5. Course Completion Survey

More

Register Today

 

Registering a group?

Get your group discount code and assistance with group registration.

Labtopia offers group training discounts for groups of 3 and more.

After submitting, if you do not receive your group discount code check your junk and spam folders. If you still do not receive your group discount code email aelmore@labtopiainc.com

 

Who should attend?

Quality assurance personnel, laboratory management, and ISO 17025 implementers interested in understanding the key milestones, necessary resources, and a realistic timeline to achieve accreditation.

Certificate of Attendance

All attendees receive a certificate of attendance upon course completion.

Discover your potential, starting today

Enroll today

8 AM - 5 PM
Monday, Jan 1, 2024 8 a.m.
Multi-day Event
Online Courses

Four-part online course

  • Part I: Why Do We Need a Quality System? – 20 minutes
  • Part II: Documents & Records – 20 minutes
  • Part III: Nonconforming Work & Deviations – 15 minutes
  • Part IV: Corrective and Preventive Action – 15 minutes

 

COURSE OVERVIEW

This four-part series provides a foundational understanding of quality management and its integral role in the functions of an efficient, well-run laboratory. Part I defines quality management and describes its benefits. Documents and records – the pillars of an effective QMS – are examined in Part II. Part III addresses nonconforming work and deviations, offering insight on how both should be addressed. Finally, Part IV differentiates between corrective and preventive action, placing each in context with regard to the QMS.

KEY LEARNING OBJECTIVES

By the end of this course, you should be able to:

  • Recognize key quality management terms
  • Articulate the benefits of quality management systems
  • Distinguish between documents and records
  • Identify good laboratory practices
  • Recognize the link between good laboratory practices and data defensibility
  • Define nonconforming work and deviations, and properly address both
  • Differentiate between corrective and preventive action
  • Understand CAPA’s role in the QMS

 

FOUR-PART SERIES INCLUDES:

QMS Part I: Why do we need a quality system?

Quality Management Training

QMS Part II: Documents & Records

Quality Management Series Part II

QMS Part III: Nonconforming Work & Deviations

Quality Management Series Part III

QMS Part IV: Corrective and Preventive Action

Quality Management Training Part IV

Bundle and Save

Regularly $99 per Part. Or bundle and get the entire four-part series of only $295!

Register Today

Registering a group?

Get your group discount code and assistance with group registration.

Labtopia offers group training discounts for groups of 3 and more.

After submitting, if you do not receive your group discount code check your junk and spam folders. If you still do not receive your group discount code email aelmore@labtopiainc.com

Who should attend?

Technical personnel new to quality management systems, new quality team members, and anyone interested in understanding the building blocks of quality management and requiring an understanding of quality management systems as applied in the laboratory.

Certificate of Attendance

All attendees receive a certificate of attendance upon course completion.

Discover your potential, starting today

Enroll today

8:30 AM - 4:30 PM
Thursday, Oct 3, 2024 8:30 a.m.
Multi-day Event
Labtopia Classroom Courses

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 Assessor"

Gain insight and best practice advice and tips from a certified ISO 17025 Lead assessor 

Course pricing

Live, in-person, two-day course with a Lead ISO 17025 Assessor

$895.00

Regular price

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Registering a group?

Get your group discount code and assistance with group registration.

Group Training Discount & Registration

Labtopia offers group training discounts for groups of 3 and more.

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, and managing the laboratory. 

Certificate of Attendance

All attendees receive a certificate of attendance upon course completion.

Student Prerequisites

Each student must bring a copy of the current ISO 17025 standard and must have working knowledge of ISO 17025 prior to attending the course.

Group Discounts

Registering a group? Contact us to get a special group discount and assistance with registering your group.

 

Discover your potential, starting today

Enroll today