Short Course - Confidence in Analytical Results & Measurement Uncertainty

Course Information

Course Title:	Confidence in Analytical Results & Measurement Uncertainty
Categories:	1 - Chemometrics 2 - Pharmaceutical Sciences 3 - Data Analysis 4 - Data Management 5 - Quality/Regulatory/Compliance 6 - Statistics
Instructor(s):	Christopher Burgess	Course Number:	131
Affiliation:	Burgess Analytical Consultancy Limited
Course Date:	03/15/2012 - Thursday	Course Length:	1 Day Course
Start Time:	08:30 AM	End Time:	05:00 PM
Fee:	$455 ($655 after 2/13/12)	Textbook Fee:

Course Description

For many years, measurement uncertainty calculations have been a requirement in ISO 17025 accredited laboratories. Recently the USP has introduced these ISO concepts into USP General Chapter <1010>; Analytical Data—Interpretation And Treatment and started the production of Certified Reference Materials which will have a major impact on the pharmaceutical and related industries. The purpose of course is to; • Describe the basic principles of measurement uncertainty and error budgets • Apply these basic principles to the calibration and qualification of analytical instruments • Allow participants to gain experience in applying the techniques to analytical method validation and method transfer. • Undertake three practical workshop exercises in; • Instrument performance and reference materials • Method performance and method transfer • Propagation of errors and their impact on the reportable value

Target Audience

This course & associated workshops is designed for analytical chemists and scientists and laboratory managers charged with the management and evaluation of laboratory data primarily in a regulated environment. QA and regulatory affairs professionals will benefit from participation by gaining a clear understanding of the latest ISO, FDA & USP requirements.

Course Outline

Introduction to Course and charting of participant learning objectives (Interactive discussion)
Basics of Measurement Uncertainty (Presentation)
Measurement Uncertainty in Calibration and Qualification of analytical instrumentation (Presentation)
Workshop 1; Instrument performance and traceable reference standards
Measurement Uncertainty in the Validation of Analytical Methods (Presentation)
Workshop 2; Method Performance and Method Transfer
Error budgets and reportable values (Presentation)
Workshop 3; Propagation of errors and the impact on reportable values

Course Instructor's Biography

Dr Burgess is a Chartered Chemist and has more than 36 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 and a member of the European QP Association advisory board. He has been appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and 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. He is also a Chartered European Chemist, a Chartered Scientist and a qualified ISO Guide 17025 assessor and was a member of the PDA Expert Working Group on Out of Specification results.