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Wednesday, November 6 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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8:30 AM - 4:30 PM
Tuesday, Nov 5, 2024 8:30 a.m.
Multi-day Event
Labtopia Classroom Courses

This highly participative three-day course provides comprehensive instruction on auditing quality management systems based on the ISO 9001:2015 requirements. The course begins with a high-level overview of ISO 9001:2015 and differences in comparison to ISO 9001:2008. Practical workshops, case studies, and simulated assessments will help you develop an understanding of how the new requirements will affect your organization and your audits. The training teaches process-based audit skills useful for both internal and external audits. Real-world audit situations allow you to practice your auditing skills and techniques, ensuring that you fully grasp the requirements of auditing to the ISO 9001:2015 standard.

“ASK THE ASSESSOR” – Gain insight, best practice advice, and tips from a certified ISO 9001 Lead Assessor!

Key session topics

  • Overview of ISO 9001:2015 requirements
  • Critical linkages between the Quality Policy, Objectives, Management Review, and internal auditing
  • Understanding risks and opportunities
  • Design and development controls
  • Determination of requirements for products and services
  • Control of externally provided products and services
  • Coordinate a quality management system audit
  • Construct an audit program and the preparation of audit checklists
  • Audit effectively
  • Prepare nonconformity statements
  • Evaluate the significance of audit findings
  • Methods for improving communication skills
  • Report audit findings and conclusions
  • Develop and implement corrective action programs
  • Evaluate corrective action responses
  • Effectively follow up on audit findings to recognize if the nonconforming situation has been effectively resolved
  • Understanding the difference between quality system registration and accreditation

Course pricing

Live, in-person, three-day course with a Lead ISO 9001 Assessor

$1,480.00

Regular price

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?

Those responsible for planning and scheduling an internal audit program for ISO 9001, those who must perform audits to ISO 9001, quality assurance managers, quality assurance professionals, ISO project managers and team members. 

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 9001 standard and must have working knowledge of ISO 9001:2015 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