2021 TUTORIALS
ORLANDO, FLORIDA USA
Rosen Shingle Creek Hotel
August 21, 2021
NCSL International Tutorial Program
ANAHEIM, CALIFORNIA USA
Disneyland Convention Center Hotel
November 17, 2021
Measurement Science Conference Tutorial Program
Spectrophotometer Qualification – Analytical Science Beyond Compliance
Chapters from USP and other international pharmacopeias on the qualification of analytical spectrophotometers and microplate readers are exceptionally vague and incomplete with respect to their information and guidance on how to provide a meaningful qualification so that the “calibration label” affixed to a given FDA-regulated laboratory instrument has merit and can be justified and defended. By transcending the fundamentals and applications of chemical metrology, this tutorial session will emphasize analytical spectrophotometric metrology as a pivotal strategy and approach to providing international harmonization on how to qualify an analytical spectrophotometer and microplate reader.
In most cases, quality assurance of the qualification of an analytical spectrophotometer or microplate reader will not be any more sound or defensible than the “calibration integrity” of the filters used to test the different instrument parameters. As such, the focus will be on science-based measurement approaches to the certification of calibration filters and the factors that impact the scientific integrity of their reference value assignments and uncertainty estimations. An innovative “calibration integrity” matrix with a numeric rating index that quantifies the scientific metrological strength of the measurement results provided in a Report or Certificate of Calibration will be introduced to help FDA-regulated laboratory managers and out-sourcing representatives select the proper company to have their calibration filters recertified.
The session will conclude with a mock scenario in which an unidentified FDA-regulated laboratory has become the focus of an external scrutiny involving its analysis results of an analytical spectrophotometer or microplate reader. An illustrative example of an aggressive line of questioning by the opposing forensic science legal team, whether it be in a deposition or in a courtroom setting, will be presented.
Bio
Dr. Jerry Messman is Analytical Scientist Emeritus at Stranaska Scientific, a small calibration and educational company recognized as a world-wide industry expert and critical thought leader in analytical spectrophotometric metrology. Jerry maintains an oversight leadership role at Stranaska Scientific as Senior Managing Director. Previously, Jerry was a former scientific leader of the NIST high-accuracy spectrophotometric standards program in the agency’s Chemical Sciences and Technology Laboratory. In the forensic science field, Dr. Messman is a qualified expert witness in the Commonwealth of Pennsylvania. Jerry has developed and presented scientific forensic metrology educational courses at analytical chemistry conferences, forensic science workshops and crime laboratories in Florida, Illinois, Oklahoma and Texas.