{"id":3362,"date":"2015-04-22T14:06:54","date_gmt":"2015-04-22T18:06:54","guid":{"rendered":"http:\/\/easinc.org\/wordpress\/?page_id=3362"},"modified":"2016-02-23T11:30:15","modified_gmt":"2016-02-23T16:30:15","slug":"e15-atomic-spectroscopy","status":"publish","type":"page","link":"https:\/\/eas.org\/2024\/e15-atomic-spectroscopy\/","title":{"rendered":"E15-29: Atomic Spectrometry"},"content":{"rendered":"
\n

Atomic Spectrometry:\u00a0 Applications of Elemental Analysis <\/span>
in the Pharmaceutical Industry<\/span>
\nOne-Day Course<\/span><\/em><\/span><\/span><\/strong><\/p>\n<\/div>\n

Dr. Timothy L. Shelbourn, Eli Lilly and Company, Indianapolis, IN
Dr. Michael DeLeon,\u00a0SPECTRO Analytical Instruments, Mahwah, NJ<\/p>\n

COURSE DESCRIPTION\u00a0
<\/strong>With the recent changes in compendia and regulatory requirements for control of elemental impurities in drug products using instrumental analysis, analytical capabilities to measure elements (atomic absorption, ICP-optical emission spectroscopy, ICP mass spectrometry, and X-ray fluorescence spectrometry ) are now a necessity for developing, manufacturing and marketing commercial drug products.<\/p>\n

This short course introduces a comprehensive overview of elemental impurities regulatory standards and guidelines (including USP <232> and ICH Q3D).\u00a0\u00a0 \u00a0Technical aspects of the major analytical techniques will be discussed with an emphasis on pharmaceutical applications and method validation practices.<\/p>\n

WHO SHOULD ATTEND<\/strong>
\nThis one-day course will benefit analysts, QA and QC managers, regulatory professionals, and researchers who develop or manufacture drug product.<\/p>\n

TOPICS
\n<\/strong>1.\u00a0 Introduction to Elemental Analysis in Pharmaceutical Products
\u00a0\u00a0\u00a0\u00a0 * Under what circumstances is atomic spectrometry applied?
\u00a0\u00a0\u00a0\u00a0 * Review of compendia (monographs and general chapters)
2.\u00a0 An Overview of USP, EP and JP Elemental Impurities Standards\u00a0
3.\u00a0 Introduction and Review of ICH Q3D
4.\u00a0 Risk Assessments and Control Strategies for Elemental Impurities<\/p>\n

5.\u00a0 Analytical Techniques
\u00a0\u00a0\u00a0\u00a0 * Atomic Absorption (flame, graphite furnace, hydride generation, cold vapor)
\u00a0\u00a0\u00a0\u00a0 *\u00a0X-ray Fluorescence
\u00a0\u00a0\u00a0\u00a0 * Inductively coupled plasma optical emission spectroscopy
\u00a0\u00a0\u00a0\u00a0 * Inductively coupled plasma mass spectrometry
6.\u00a0 Analytical Method Validation<\/p>\n

Case studies will be presented to illustrate several risk assessment and control strategy scenarios for elemental impurities in drug product.<\/a><\/strong><\/p>\n

ABOUT THE INSTRUCTOR
\nTimothy\u00a0L. Shelbourn<\/strong>\u00a0
Education:
MS Chemistry, Roosevelt University, Chicago, Illinois\u00a0
MBA, Webster University, St. Louis, Missouri\u00a0
BS Agrulculture, University of Nebraska, Lincoln, Nebraska<\/p>\n

Employment History:\u00a0
2003-Present\u00a0Research Scientist, Pharmaceutical R&D, Eli Lilly and Company
1986-2003:\u00a0Research Scientist, Corporate Technology Resources, Baxter Healthcare<\/p>\n

Affiliations:\u00a0
2014-Present: \u00a0American Chemical Society, Atomic Spectroscopy Subject Matter Expert for SciMind web based education series on atomic spectroscopy<\/p>\n

2005-Present: \u00a0<\/span>United States Pharmacopeia, General Chapters Expert Committee member<\/p>\n

Michael DeLeon,<\/strong>\u00a0is an Applications Scientist for Spectro Analytical Instruments for their X-ray Fluorescence and Spark Optical Emission Spectroscopy products.\u00a0 Dr. DeLeon\u2019s academic career includes a wealth of experience in a variety of analytical techniques such as AFM, TEM, High Resolution XRD, XAS, NEFS, TEY, and SEM-XRF.\u00a0 Much of his research during his time with the New Jersey Institute of Technology was conducted at the National Synchrotron Light Source in Brookhaven National Labs. His focus was on the analysis strongly correlated electronic systems. Michael has used a variety of thin layer deposition techniques such as Pulsed Laser Deposition (PLD) (Naval Research Laboratories) and Metal-Organic Chemical Vapor Deposition (MOCVD) (in the Centre National de la Recherche Scientifique) for the manufacture of thin films from single monolayer to large crystalline layers.<\/p>\n

Dr. DeLeon\u2019s professional career as an Applications Scientist for Spectro Analytical Instruments for the X-ray Fluorescence and Spark Optical Emission Spectroscopy products lines, he work closely with sales, marketing, research and development, product management, service, and, of course, a wide customer base.\u00a0 The industries he has worked closely with include: pharmaceutical, consumer goods, petrochemical, geological, and various metals industries. Michael also participates in ASTM committees to further international standards and specifications crucial for the various industries we serve.<\/p>\n","protected":false},"excerpt":{"rendered":"

Atomic Spectrometry:\u00a0 Applications of Elemental Analysis in the Pharmaceutical Industry One-Day Course Dr. Timothy L. Shelbourn, Eli Lilly and Company, Indianapolis, INDr. Michael […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3362","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3362"}],"collection":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/comments?post=3362"}],"version-history":[{"count":6,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3362\/revisions"}],"predecessor-version":[{"id":3899,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3362\/revisions\/3899"}],"wp:attachment":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/media?parent=3362"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}