Keynote Speaker: Fit for Purpose: Metrology, the United States Pharmacopeia & Measurement Uncertainty – Wednesday, February 4
- Start Date : 4 February, 2026
- Start Time : 12:15pm
- End Date : 4 February, 2026
- End Time : 1:30pm
- Address : Grand Hall E-G
No Schedule
a. The United States Pharmacopeia (USP) is focusing on ensuring measurements are fit for purpose. This requires a metrological approach to its test methods, instrument qualification, and standard writing. Measurement uncertainty is a critical component for this metrological approach. The presentation will present the USP’s use of metrology with the emphasis that our drugs and biologics are efficacious and safe. This includes evaluating and using measurement uncertainty to ensure the laboratory instruments are qualified adequately and that the test methods are “good enough”.
b. This talk is relevant to the conference attendees because people and companies that work with the USP are and will need to understand and know how to meet the requirements. This applies to any organization that uses the USP standards, including pharmaceutical, biological, dietary supplement, and food industry.
Jane Weitzel, Biosketch
Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies. Recently she wrote the new chapter on Chemical and Biological Measurements and Uncertainties for The ASQ Metrology Handbook Third Edition. Her dedication now is to introduce, implement and use the metrological approach to measurements in the pharmaceutical industry. She was elected to the United States Pharmacopeia Council of Experts as chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee and is a member of the 2025-2030 EC Pharmaceutical Analysis Lifecycle and Data Science. She was a member of the USP 2015-2020 Statistics Expert Committee. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments. She is currently a consultant specializing in laboratory management systems, GMP testing, and ISO/IEC 17025. She is an auditor and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. Recently she is focusing on the implementation of the new USP General Chapter Analytical Procedures Life Cycle.