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Short Course

Course Information
Course Title: Trace Level Method Development and Validation Practice in the Pharmaceutical Industry
Categories: 1 - Mass Spectrometry
2 - Quality/Regulatory/Compliance
3 - Gas Chromatography-Mass Spectrometry
4 - Validation
Instructor(s): Gyorgy Vas Course Number: 154
Affiliation: Johnson&Johnson
Course Date: 03/19/2013 - Tuesday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $260 ($360 after 2/18/13) 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 using highly selective methodology such as 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
This course is designed for analytical chemists, quality, and regulatory personnel involved in trace level (<10 ppb level) analyses in the regulated pharmaceutical environment.

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

Course Instructor's Biography
Dr. Gyorgy Vas is a Principal Scientist with Johnson & Johnson, Product and Process Scientific Solutions, Analytical Development in Raritan, NJ. He currently specializes in solventless sample preparation techniques such as SPME and Stir Bar Sorptive Extraction. He is responsible to complete trace level method development and validation projects supporting pharmaceutical products and medical devices. He received M.Sc. in Analytical Chemistry from University of Debrecen (Hungary) and his Ph.D. in mass spectrometry from University of Eotvos (Hungary). He has published 16 research papers and has recently received the Johnson & Johnson Outstanding Analytical Scientist Award and the Philip B. Hoffman Research Award for developing trace level analytical methods. He has worked for Johnson & Johnson for six years and previously held various academic and industrial positions at performing mass research related to mass spectrometry. Dr. Gail Reed is an R&D Manager of an Analytical Chemistry group at McNeil Consumer Healthcare, Fort Washington, PA. Her group currently develops and validates analytical methods for OTC drug products. She received a B.S. degree in Chemistry from Millersville University and a Ph.D. in analytical chemistry, specializing in chromatography, from Virginia Tech. She previously worked for Cordis supporting analytical method development for drug-eluting stents, including trace level analyses, and Janssen where she developed and validated methods for drug products.