WEBINAR

Data Integrity in Support of Data Defensibility

Data defensibility 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 data is generated using proper laboratory techniques. This webinar covers common indicators for laboratory fraud and addresses how laboratory management can implement strategies to ensure that data is defensible and complete. The webinar also provides best practices and establishes expectations for the proper methods of testing and reporting sample information.

Key Takeaways

  • Proper Data Generation
  • Laboratory Fraud Indicators
  • Best Practices – Information Reporting

Audience Questions

At the end of the webinar, questions were asked by the webinar’s attendees. These included:

  • Someone adjusted an oven setting after it was externally calibrated. Is this considered unethical?
  • How widespread do you believe that data fraud is?
  • Do you believe that data integrity is primarily the operator’s responsibility?
  • Are operators responsible for the unintentional or intentional consequences of the deviations that they cause?
  • You discussed quality data briefly, can you expand more on that?
  • When are we not allowed to integrate chromatography peaks?

Presenter

Jeanné Mensingh, President, Labtopia, has over 30 years’ experience in the laboratory as an analytical chemist, lab manager, and quality systems manager. She 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 ISO 9001:2000 lead auditor, EPA Certified Drinking Water Microbiology, Inorganics and Organics, ISO 17025 Lead Assessor (A2LA, NELAP/AOAC/QSM) and is a Lead Assessor for NELAP (TCEQ, MNELAP, FL DoH, and LDEQ). She has extensive experience in wet chemistry, chromatography, and spectroscopy.

Jeanné Mensingh, President, Labtopia

Keith Mowry is Senior Manager of Business Development at ANAB. He is a member of ISO CASCO Working Group 29 developing the Amendment to ISO/IEC 17065 and serves as ANAB’s representative on the ANSI International Conformity Assessment Committee (ICAC), which he chaired for over 20 years. He has over 30 years of experience with ISO standards and guides for conformity assessment. Jeanné Mensingh, President, Labtopia, has over 30 years’ experience in the laboratory as an analytical chemist, lab manager, and quality systems manager.  She 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 ISO 9001:2000 lead auditor, EPA Certified Drinking Water Microbiology, Inorganics and Organics, ISO 17025 Lead Assessor (A2LA, NELAP/AOAC/QSM) and is a Lead Assessor for NELAP (TCEQ, MNELAP, FL DoH, and LDEQ).  She has extensive experience in wet chemistry, chromatography, and spectroscopy. 

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