×

Wednesday, July 22 2020

Wednesday, Jan 1, 2020 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, lab analysts, lab managers, quality managers, and plant managers.


Group Discount:

Group Discounts are available! Contact a Labtopia representative for your unique discount code Group Discount Code Request 

 

8:30 AM - 4:30 PM
Wednesday, Jul 22, 2020 8:30 a.m.
Multi-day Event
Labtopia Classroom Courses

Course Overview:

 

This highly participative 2-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 the differences between ISO 9001:2015 and ISO 9001:2008. 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 9001:2015 standard.  

Student Prerequisites:  Each student shall be required to have studied the current published version of ISO 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.

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 audit findings to recognize if the nonconforming situation has been effectively resolved
  • Understanding the difference between quality system registration and accreditation

 

Student Prerequisites:  Each student shall be required to have studied the most newly revised version of ISO/IEC 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

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.