For many years, measurement uncertainty calculations have been a requirement in ISO 17025 accredited laboratories. The USP has introduced these ISO concepts into USP General Chapter <1010>; Analytical Data—Interpretation And Treatment and <1210> Statistical tools for Procedure Validation which will have a major impact on the pharmaceutical and related industries. The newly proposed USP General Chapter <1220> on Analytical Procedure Lifecycle includes the need to consider measurement uncertainty as part of ‘fitness for purpose’.
1. Introduction to Course and charting of participant learning objectives (Interactive discussion)
2. Basics of Measurement Uncertainty (Presentation)
3. Measurement Uncertainty in Calibration and Qualification of analytical instrumentation (Presentation)
4. Workshop 1; Instrument performance and traceable reference standards
5. Measurement Uncertainty in the Validation of Analytical Methods (Presentation)
6. Workshop 2; Method Performance and Method Transfer
7. Error budgets and reportable values (Presentation)
8. Workshop 3; Propagation of errors and the impact on reportable values
Dr. Burgess has more than 40 years’ experience in the pharmaceutical industry primarily with Glaxo (now GSK) in Quality Control, Quality Assurance and Analytical R&D. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2020 and is a member of the Expert Panel on Validation and Verification of Analytical Procedures developing USP General Chapter . He is a visiting professor of the University of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS). In addition, he is a qualified ISO Guide 17025 assessor a. He is an editorial board member of Pharmaceutical Technology and author of the Statistical Solutions columns.