Short Course Listings
 
Short Course

Course Information
Course Title: Confidence in Analytical Results and Measurement Uncertainty
Categories: 1 - Data Analysis
2 - Data Management
3 - Quality/Regulatory/Compliance
4 - Statistics
5 - Validation
Instructor(s): Chris Burgess Course Number: 106
Affiliation: Burgess Analytical Consultancy Limited
Course Date: 03/08/2017 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

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 and started the production of Certified Reference Materials which will have a major impact on the pharmaceutical and related industries. The newly announced proposed USP General Chapter <1220> on Analytical Procedure Lifecycle includes the need to consider measurement uncertainty as part of ‘fitness for purpose’. 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 is designed for analytical chemists, senior technicians and analytical laboratory managers involved in management and evaluation of laboratory data primarily in a regulated environment. QA and regulatory affairs professionals will also benefit from participation by gaining a clear understanding of the latest ISO, FDA & USP requirements.

Course Outline
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

Course Instructor's Biography
Dr Burgess is a Chartered Chemist and 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 is a “QP”, Qualified Person, in the European Union and a member of the European QP Association advisory board. He was appointed to the United States Pharmacopoeia’s Council of Experts 2010 to 2015 and 2015 to 2020. 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. 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. He is an editorial board member of Pharmaceutical Technology and author of the Statistical Solutions column.