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Live - Data Integrity & Ethics Training

Dec. 6, 2019

Live Webinar


Event has ended

Description

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.

 


Featured Speakers

Speaker Jeanne' Mensingh
Jeanné Mensingh is one of the co-founders of Labtopia. Jeanné has extensive experience in regulated industries and laboratories.  As a subject matter expert (SME) she assists regulated laboratories in streamlining their processes, leaning their operations, and meeting any regulatory requirements with automated systems such as LIMS.  In addition she provides …

Jeanné Mensingh is one of the co-founders of Labtopia. Jeanné has extensive experience in regulated industries and laboratories.  As a subject matter expert (SME) she assists regulated laboratories in streamlining their processes, leaning their operations, and meeting any regulatory requirements with automated systems such as LIMS.  In addition she provides quality assurance support to manufacturers, laboratories, and distributors related to ISO, GxP, and Environmental requirements.  She has extensive experience in all aspects of laboratory operation from the analytical bench to QA management in the plant and commercial laboratory environment.  Her background in quality management systems, technical writing, project management, business process mapping, database requirements and implementation, document control, validation, and laboratory compliance support her clients in all aspects of quality and regulatory requirements.  


Jeanné has an ACS Certified B.S. in Chemistry from Northeast Louisiana University (now University of Louisiana at Monroe) and post graduate work in Chemical Engineering at Louisiana Tech University.  She has a Masters Certificate in IS/IT Project Management from Villanova University. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified HACCP Auditor (CHA) and a Certified Software Quality Engineer (SQE).  She is also a certified Lead  Assessor for ISO 17025, ISO 9001, TNI, DoD/QSM, and AOAC. She is also an EPA Drinking Water Certification Office for Inorganic, Organic, and Microbiology. She has received training in Good Laboratory Practices, Good Manufacturing Practices and International Pharmaceutical Excipient Council Good Manufacturing Practices for Excipients.


When she finds time to relax, Jeanné enjoys spending time with her husband Paul Mensingh and their two sons, Gabriel and Christian.  As an extensive traveler, Jeanné still finds time for her hobbies as a pastel artist, avid book reader, and scrap-booker.


Read more about Jeanne’s qualifications and current projects. https://www.linkedin.com/profile/view?id=30387926&authType=NAME_SEARCH&authToken=G-Bw&locale=en_US&trk=tyah2&trkInfo=tarId%3A1415287451444%2Ctas%3Ajeanne%2Cidx%3A1-2-2">http://www.labtopiainc.com/files/139/" alt="LinkedIn.png" width="31" height="31" />

Full Description



Organizer

Labtopia Training

At Labtopia Training, we are scientific and technical professionals just like you. Therefore, we understand the unique challenges you face in your workplace.  With over 25 years of industry experience, we understand the importance of consistent, effective training programs.


Date and Time

Fri, Dec. 6, 2019

10 a.m. - noon
(GMT-0500) US/Central

Location

Live Webinar



Labtopia's Online Classroom: Access instructions and login credentials will be provided upon paid registration.    

Event has ended