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Short Course

Course Information
Course Title: (CANCELED) Trace Level Analytical Method Validation in Pharmaceutical and in Food Industry
Categories: 1 - Sample Preparation
2 - Gas Chromatography-Mass Spectrometry
3 - Validation
Instructor(s): Gyorgy Vas Course Number: 133
Affiliation: Intertek/VasAnalytical
Course Date: 03/06/2017 - Monday 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
This course discusses method validation of trace level components in the pharmaceutical industry. Conventional pharmaceutical method validation practices are not always applicable to trace level analyses. Working at trace level analysis the quality and performance of the instruments are critical and usually trace level analysis is achieved by using highly selective methodology such as mass spectrometry and tandem mass spectrometry, unlike conventional pharmaceutical practices. Recent developments (e.g. recalls and more stringent requirements for medical devices) in the pharmaceutical industry are demanding lower detection limits beyond previously defined genotoxic impurities limits (~1 ppm). A review of relevant guidances from various industries will be presented. Several examples requiring trace level analysis validation will be discussed.

Target Audience
Scientist and laboratory managers form Food and Pharmaceutical Industry. This course is also target for QA auditors and QA managers.

Course Outline
Key points for trace level method validation Review of relevant guidances and industry practices Review of relevant instrumental and sample preparation techniques Aspects of instrument performance and qualification Examples of trace level method validation in the pharmaceutical industry

Course Instructor's Biography
Dr. Gyorgy Vas has a M Sc in Analytical Chemistry and a Ph. D. in Mass Spectrometry. He had published 18 research papers that have been cited more than 1600 times. Dr. Vas has several years of experience in E&L testing, pioneering and adopting solventless analytical sample preparation techniques. He has multiple years of experience for developing trace level analytical methods and validating methods at trace level. He worked for Johnson & Johnson for 7 years and was recipient of Johnson & Johnson Outstanding Analytical Scientist Award and the Philip B. Hofmann Research Award. Currently he is holding position in Intertek as a Business Technical Scientific Liaison