Confidence in Analytical Results and Measurement Uncertainty
Presented by Christopher Burgess, BAC Limited
Tuesday, May 17, 2022 ◉ 1:00 pm to 3:00 pm EST
COURSE DESCRIPTION: 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. The new USP General Chapter <1220>on Analytical Procedure Lifecycle includes the need to consider measurement uncertainty as part of ‘fitness for purpose’. There is a new USP initiative to extend the application of measurement uncertainty as part of ‘fitness for use’ to USP General Chapter <1058>; Analytical Instrument Qualification.
TARGET AUDIENCE: This course is designed for analytical chemists, senior technicians and analytical laboratory managers involved in evaluation of laboratory data primarily in a regulated environment. In addition, QA and regulatory affairs professionals will benefit from participation by gaining a clear understanding of the latest ISO, FDA & USP requirements.
• Describe the basic principles of measurement uncertainty and error budgets
• Apply basic principles to the calibration and qualification of analytical instruments and to analytical procedure validation.
CATEGORIES: Analytical Metrology, Data Analysis, Data Management, Statistics, Validation
About the Instructor
Dr. Burgess is a Chartered Chemist and has more than 45 years experience in the pharmaceutical industry primarily with Glaxo (now GSK) in Quality Control, Quality Assurance and Analytical R&D. He is a “QP”, Qualified Person, in the European Union. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2020 and again 2020 to 2025 and is a member of the Joint Sub Committee for developing USP <1220> and chair of the Joint Sub Committee revising <1058>. He is a visiting professor of the University of Strathclyde’s School of Pharmacy and Biomedical Sciences (SIPBS). In addition, he is the chairman of the ECA Analytical Quality Control Group and a member of the Executive committee of European Compliance Academy.