Short Course Listings
Short Course

Course Information
Course Title: A Practical Guide to the New Global Guidelines on Elemental Impurities and Analytical Procedures for Pharmaceutical Materials and Dietary Supplements
Categories: 1 - Atomic Spectrometry-Spectroscopy
2 - Mass Spectrometry
3 - Pharmaceutical Sciences
4 - Spectroscopy
5 - Inductively Coupled Plasma
Instructor(s): Robert Thomas Course Number: 37
Affiliation: Scientific Solutions
Course Date: 03/07/2017 - Tuesday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $325 ($425 after 2/18/17) Textbook Fee: $86

Course Description
The aim of the course is to provide a basic understanding and practical perspectives of the new elemental impurity permitted daily exposure (PDE) levels and analytical methodologies described in USP Chapters <232>, <233> and <2232> and how they are aligned with ICH Q3D Step 4 Directives.

Target Audience
People in the pharma/nutra industries who are responsible for running the new plasma-based methods for the measurement of elemental impurities. Attendees should have used trace element techniques, such as ICP-OES, but also have a basic knowledge of ICP-MS. The course will also be useful for supervisors who want to learn about the new methods.

Course Outline
The Short Course will explain in greater detail all three USP Chapters, including Chapter<232> on Elemental impurity Limits, Chapter >233> on Elemental Impurity Analytical Procedures in pharmaceutical materials and Chapter <2232> on elemental contaminants in dietary supplements, and give an historical perspective and timelines on how these new limits and procedures have been aligned with ICH (International Conference on Harmonization of the Technical Requirements for Registration of Pharmaceuticals for Human Use) directives. It will also discuss which techniques are most appropriate to use and describe sample preparation procedures; calibration routines and how best to meet the strict quality control validation protocols that are an essential component of analyzing samples according to the new guidelines.

Course Instructor's Biography
Robert Thomas has worked in trace element analysis for over 40 years - 12 years as an analytical chemist in the metallurgical industry - 22 years in application support, product development and marketing for a manufacturer of ICP-MS instrumentation, and 12 years as principal of his own consulting company. He has served on the ACS Reagent Chemical Committee for the past 12 years where he has worked closely with the United States Pharmacopeia to align the testing procedures for elemental impurities in reagent chemicals with those of pharmaceutical and neutraceutical materials. He has authored over 80 publications on trace element analysis and written three textbooks on the fundamental principles and real-world applications of ICP-MS. His most recent book entitled “Practical Guide to ICP-MS: a Tutorial for Beginners” includes a chapter dedicated to the analysis of pharmaceutical products. He has a graduate degree in Analytical Chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC), Chartered Chemist (CChem) and Chartered Scientist (CSci).