2015 Catalog USP Global Education and Training offers the unique opportunity to learn how to effectively interpret and apply U.S. Pharmacopeial Convention’s (USP) internationally recognized standards directly from USP and the experts who help set them. Only USP courses are guaranteed to have been delivered by USP and its experts. USP Approved Instructors are selected for their expertise and trained to be educators. The biographies that follow list the approved course topics the instructors can teach. 2015 Instructors Latin America BRAZIL Lilian Tenório Quirante USP Affiliation: Education: USP–Brazil employee since 2008 Senior Manager, Quality Assurance and Regulatory Affairs B.S., Chemistry B.S., Pharmacy and Biochemistry Glaucia Karime Braga USP Affiliation: Course Topics: Affiliated with USP since 2012 Member of Good Distribution Practices Expert Panel Good Documentation Practices; Good Laboratory Practices; Good Manufacturing Practices Company: Fundação para o Remédio Popular (FURP) Fernanda Spoljaric Education: B.S., Pharmacy, Universidade de São Paulo USP Affiliation: USP–Brazil employee since 2012 Associate Liaison, Medicines Compendium Latin America Education: B.S., Chemistry, Universidade de São Paulo M.S., Pharmaceutical Sciences, Universidade de São Paulo Ph.D., Pharmaceutical Sciences, Universidade de São Paulo Course Topics: Packaging, Storage, and Distribution; Compounding Wanderson Guimarães USP Affiliation: Education: Course Topic: M.S., Analytical Chemistry, Universidade de São Paulo Ph.D., Analytical Chemistry, Universidade de São Paulo Course Topic: Analytical Method Validation USP–Brazil employee since 2008 Group Leader, Reference Standards M.S., Pharmacy and Biochemistry, Federal University of Juiz de Fora Dissolution Fundamentals East Asia CHINA Rafael Finocchiaro Maranho USP Affiliation: Affiliated with USP since 2008 Company: Faculty, Universidade de São Paulo Education: B.Sc., Pharmacist-Biochemist, Faculty of Pharmaceutical Sciences, University of São Paulo (Ribeirão Preto, SP) M.Sc., Chemical and Biochemical Technology, Institute of Chemistry, University of São Paulo (São Paulo, SP) Course Topics: Kevin H.X. Cao USP Affiliation: Education: Impurities in Drug Substances and Drug Products; Validation and Verification of Analytical Procedures Denis Alexandre Ramlho Padeiro Education: Course Topics: USP–Brazil employee since 2012 Group Leader, Monograph Modernizations Jim Z. Lu B.S., Chemistry, Osvaldo Cruz USP Affiliation: High Performance Liquid Chromatography (HPLC); Impurities; Forced Degradation Studies; Validation and Verification; Method Transfer B.S., Economics, Shenyang Pharmaceutical University, China M.B.A., East China University of Science and Technology, China Course Topics: USP Affiliation: USP–China employee since 2007 Director, Customer Relationship Management Education: Course Topics: USP Reference Standards Overview; Intro to USP–NF USP–China employee since 2007 Director, QA B.S., Biochemistry, East China University of Science and Technology Microbiological Testing; Pharmaceutical Waters Questions? Email Education@usp.org. 3 R Fred Xi USP Affiliation: Education: Chris Jones USP–China employee since 2013 Vice President, Chemicals Ph.D., Medicinal Chemistry, Peking Union Medical College, Chinese Academy of Medical Sciences Postdoc fellowship training, University of Toronto Course Topics: HPLC; Residual Solvents; Elemental Impurities; Impurities in Drug Substances and Drug Products USP Affiliation: Affiliated with USP since 2010 Chair, USP Expert Panel on Glycoprotein And Glycan Analysis Company: Head of Division, Laboratory for Molecular Structure, NIBSC, UK Education: B.Sc., ARCS, Imperial College London Ph.D., University of Southampton PDRA, University of Cambridge Course Topic: Glycoprotein and Glycan Analysis Johannes Krämer USP Affiliation: CEO, PHAST GmbH and flexible 4 Science GmbH Education: Degree in Pharmacy, Johann Wolfgang GoetheUniversity, Frankfurt am Main/Germany Ph.D., Pharmaceutical Technology and Biopharmaceutics, Ruprechts-Karls-University, Heidelberg, Germany Europe/Middle East/Africa SWITZERLAND USP Expert Committee member since 1992 Company: Course Topics: Developing and Validating Dissolution Methods; Dissolution; In-Vivo In-Vitro Correlation (IVIVC) Carmel M. Molloy USP Affiliation: Alex Fiechter USP Affiliation: USP–Europe/Middle East/Africa employee since 2005 Senior International Account Manager Course Topics: Dissolution Fundamentals; Intro to USP–NF Education: Course Topics: M.Sc., Chemistry, Trinity College, University of Dublin, Ireland Elemental Impurities; Dissolution Overview; Intro to USP–NF Barbara Mulloy Elaine Gray USP Affiliation: Affiliated with USP since 2006 Member USP Expert Committee Biologics and Biotechnology 2; Member USP Expert Panel, Unfractionated Heparin; Co-chair USP Expert Panel, Low Molecular Weight Heparin; Member USP Expert Panel, Plasma Protein Analytical; Member USP Expert Panel, Recombinant and Plasma-Derived Coagulation Factors USP Affiliation: and Control (NIBSC) Education: B.Sc., (Hons) Biological Sciences Ph.D., “Lipoproteins, blood coagulation and thrombosis,” Council for National Academic Awards (CNAA)/NIBSC Course Topic: Heparin Sodium Monograph Test Methods For the latest course information, visit http://education.usp.org. Affiliated with USP since 2007 Member USP Expert Committee Biologics and Biotechnology 1; Member USP Expert Panel, Unfractionated Heparin; Member USP Expert Panel, Low Molecular Weight Heparin Company: Consultant Education: B.Sc., (Hons) Biochemistry Ph.D., Chemistry, University of London Company: National Institute for Biological Standards 4 USP–Europe/Middle East/Africa employee since 2010 Senior International Account Manager Course Topic: Heparin Sodium Monograph 2015 Instructors Benoit Rime USP Affiliation: Education: Satheesh K. Shetty USP–Europe/Middle East/Africa employee since 2006 Senior International Account Manager Education: B.S., Chemistry, University of Bordeaux, France B.A., Business Administration, University of Paris-Sorbonne, France Course Topics: USP Affiliation: Dissolution Fundamentals; USP Reference Standards Overview; Intro to USP–NF Course Topic: INDIA Education: USP Reference Standards Overview Affiliated with USP since 2011 Company: Professor, Indian Institute of Science, Department of Biochemistry Education: M.Sc., Microbiology, M.S. University, Baroda, India M.Sc., Microbiology and Chemistry, Ruia College, Bombay, India Ph.D., Biochemistry, Indian Institute of Science, Bangalore, India Ashok Dang USP Affiliation: Ph.D., Chemistry, Jawaharlal Nehru Technological University, Hyderabad, India Utpal S. Tatu USP Affiliation: South Asia USP–India employee since 2006 Director USP–India employee since 2006 Senior Director Course Topic: Bioassay Validation M.Sc. (Hons) Chemistry, Panjab University, Chandigarh, India M.B.A., Marketing, Maharshi Dayanand University, Rohtak, India Ph.D., University School of Management, Kurukshetra University, India Course Topics: North America Intro to USP–NF, Product Quality in Supply Chain USA K.V. Surendra Nath USP Affiliation: Education: USP–India employee since 2006 Senior Vice President B.Sc. (Hons) Chemistry, Osmania University, Hyderabad, India D. Scott Aldrich M.S., Analytical Chemistry, ITT, Roorkee, India USP Affiliation: USP Expert Committees since 2005 Company: President and Principal Consultant, Ultramikro LLC Education: B.S., Western Michigan University Ph.D., Chemistry, University of Roorkee, India Course Topics: Validation of Compendial Procedures; Intro to USP–NF; cGMP for API’s; cGMP for Dietary Supplements; Product Quality in Procurement and Supply Chain Sameer Navalgund USP Affiliation: Education: USP–India employee since 2010 Vice President, Research and Development MHRDM, Human Resources Management, Mumbai, India Ph.D., Analytical Chemistry, Mumbai University, Mumbai, India Course Topics: Course Topic: Particulate Matter Fouad Atouf USP Affiliation: Education: Course Topic: USP employee since 2006 Director, Biologics Biotechnology—USP–NF Ph.D., Cell Biology, Pierre & Marie Curie University, Paris, France Cell Manufacturing Validation and Verification of Analytical Procedures Questions? Email Education@usp.org. 5 R John B. Atwater USP Affiliation: Education: USP employee since 2001 Senior Director, Verification Programs B.A., Chemistry, Colorado College Antonio Hernandez-Cardoso USP Affiliation: Education: Ph.D., Analytical Chemistry, Colorado State University Course Topics: cGMPs for Dietary Supplements; Food Ingredients Anthony Bevilacqua USP Affiliation: Affiliated with USP since 1994 Chair, USP Pharmaceutical Water Expert Committee Company: Director, Research and Development, Mettler-Toledo Thornton Education: Ph.D., Analytical and Physical Chemistry, Tufts University Course Topic: Pharmaceutical Waters Donna Bohannon USP Affiliation: Education: Course Topics: USP employee since 2011 Scientific Liaison, USP BSP., University of Maryland School of Pharmacy USP Affiliation: USP employee since 1981 Senior Scientific Liaison Education: B.S., Chemistry, University of Maryland Course Topics: Performance Verification Testing (PVT); Uniformity of Dosage Units B.Sc., Chemist Pharmacist Biologist, Autonomous National University of Mexico M.Sc., Clinical and Epidemiological Research, Autonomous National University of Mexico Course Topic: Pharmaceutical Waters Anthony C. Celeste USP Affiliation: Affiliated with USP since 2014 Company: Senior Advisor for Pharmaceutical Regulatory Affairs, FDA–25 years Education: EAS Consulting B.S., Chemistry, Fordham University Course Topic: Good Documentation Practices Holly Chang USP Affiliation: Education: Course Topics: Prescription Drug Labeling; Safe Medication Use William E. Brown USP employee since 2005 Senior Scientific Liaison USP employee since 1999 Senior National Account Manager B.S., Chemistry, West Virginia University, Morgantown, WV Dissolution Fundamentals; USP Reference Standards Overview; Intro to USP–NF; Intro to PF Online Kevin Correa USP Affiliation: Education: USP employee since 2012 Senior National Account Manager B.A., Chemistry, University of Massachusetts, Amherst M.B.A., Marketing, University of Phoenix Course Topics: Dissolution; USP–NF; Reference Standards; Balances Scott Burger USP Affiliation: Affiliated with USP since 2005 USP Biologics and Biotechnology Cell and Gene Therapy Expert Committee Company: Consultant Education: B.S., Biology, Tulane University M.D., University of Pennsylvania School of Medicine Course Topic: 6 Cell Therapy For the latest course information, visit http://education.usp.org. Paul J. Cowan USP Affiliation: Education: Course Topics: USP employee since 2002 Director of Sales, Europe, Middle East, Africa, and Asia B.S., Industrial Administration and Marketing, Iowa State University Elemental Impurities; Dissolution Fundamentals; USP Reference Standards Overview; Intro to USP–NF 2015 Instructors Behnam Davani USP Affiliation: Education: USP employee since 1999 Director, Monograph Modernization M.B.A., Webster University, St. Louis, MO Mary G. Foster USP Affiliation: Consultant Education: PharmD, University of Kentucky Ph.D., Analytical Chemistry, New Mexico State University Course Topics: USP Expert Committee member since 2005 Company: B.S., Pharmacy, University of Kentucky B.F.A., Western Kentucky University Method Transfer; USP–NF; Impurities; Validation and Verification of Analytical Procedures Teaching Certificate, Western Kentucky University Course Topic: Good Distribution Practices Natalia Davydova USP Affiliation: Education: USP employee since 2001 Scientific Liaison Ph.D., Chemistry, Institute of High Purity Chemicals, Moscow, Russia M.S., Chemistry, Moscow State University, Russia Course Topics: Christine Hiemer USP Affiliation: Education: Course Topics: Dissolution Testing for Pharmaceuticals and Dietary Supplements; Intro to USP–NF; HPLC; Residual Solvents USP employee since 2008 Senior National Account Manager B.S., Environmental Science/Environmental Chemistry, Rutgers University Elemental Impurities; Intro to FCC; USP Reference Standards Overview; Intro to USP–NF Galina Holloway Michael Eakins USP Affiliation: Affiliated with USP since 2005 Vice-Chair, USP Packaging and Storage Expert Committee Company: Principal Consultant, Eakins & Associates Education: Ph.D., London University Course Topic: Extractables and Leachables Education: USP Employee since 2006 Scientific Liaison, Excipients M.S., Organic Chemistry, Moscow State University, Russia Ph.D., Chemical Enzymology, Moscow State University, Russia Course Topic: Excipient Performance Barbara Hubert Joseph Eaton USP Affiliation: USP Affiliation: USP employee since 2002 Senior National Account Manager Education: B.S., Chemistry, Virginia Polytechnic Institute and State University Course Topics: Elemental Impurities; Dissolution Fundamentals; Apparatus 4; USP Reference Standards; USP–NF; Validation and Verification of Analytical Procedures USP Affiliation: Education: USP employee since 1980 Vice President, Sales and Marketing B.S., Chemistry, Virginia Commonwealth University M.B.A., Management of Science, Technology and Innovation, George Washington University Course Topics: Elemental Impurities; Dissolution Fundamentals; USP Reference Standards Overview; Intro to USP–NF L.V. Feyns USP Affiliation: Affiliated with USP since 1978 Company: Consultant Education: B.S., Chemical Engineering, Polytechnic Institute, Bucharest, Romania Ph.D., Organic Chemistry, Polytechnic Institute, Timishoara, Romania Course Topic: Uniformity of Dosage Units Questions? Email Education@usp.org. 7 R Ruud Hulspas USP Affiliation: USP Expert Committee Member since 2013 Company: Vice President Scientific Affairs, Cytonome, LLC Education: Ph.D., Cell Biology, University of Amsterdam Course Topic: Education: USP Affiliation: Cytometry Desmond G. Hunt USP Affiliation: Patricia Clancy Kienle USP employee since 2005 Senior Scientific Liaison Company: Director, Accreditation and Mediation Safety, Cardinal Health Pharmacy Solutions Education: B.Sc., Pharmacy, Philadelphia College of Pharmacy and Science M.S., University of Texas at Austin M.P.A., Health Service Administration, Marywood College, Scranton, PA Ph.D., University of Texas at Austin Course Topics: Extractables and Leachables; Good Storage and Shipping Practices Affiliated with USP since 2010 Member, Compounding Expert Committee; Chair, Hazardous Drug Subcommittee; Chair, Hazardous Drug Expert Panel; Member, Safe Medication Distribution Subcommittee Course Topic: Compounding Afsaneh Motamed-Khorasani Samina Hussain USP Affiliation: Affiliated with USP since 2014 USP Consultant Company: Metals Department Manager/Principal Investigator, Exova, Inc. Education: B.S., Chemistry, California Polytechnic University, Pomona Course Topic: USP Affiliation: Education: USP employee since 2013 Senior Pharmacopeial Education Liaison M.S., Molecular Biology/Infertility/Invitro Fertilization, University of British Columbia Ph.D., Molecular Biology/Cancer Informatics, University of Toronto Post-Doctoral Fellowship, Microbix Biosystems, Inc. Elemental Impurities Course Topic: Good Documentation Practices for the GMP Eric Kastango USP Affiliation: Affiliated with USP since 2005 Member USP Council of Experts, Compounding Expert Committee Company: Consultant Education: B.S., Pharmacy, Massachusetts College of Pharmacy and Allied Health Sciences M.B.A., University of Phoenix Course Topic: Compounding Peihong Liang USP Affiliation: Education: USP employee since 2012 Senior Pharmacopeial Education Liaison B.S., Chemistry, Jilin University, China M.S., Analytical Chemistry, University of Florida M.S., Chemistry, Peking University Course Topics: Method Transfer; HPLC; Chromatography; Dissolution; Pharmaceutical Stability; Spectroscopy; Validation and Verification of Analytical Procedures Markus Lipp USP Affiliation: Education: Course Topic: 8 For the latest course information, visit http://education.usp.org. USP employee since 2012 Senior Director, Food Standards Universität Karlsruhe (TH) Food Ingredients 2015 Instructors Angela Long USP Affiliation: Education: Kevin Moore USP employee since 1990 Senior Vice President, Global Alliances and Organizational Affairs B.S., University of Maryland USP Affiliation: Education: General Notices Margareth R. C. Marques USP Affiliation: Education: USP employee since 1990 Senior Scientific Liaison B.S., Pharmacy, University of São Paulo Course Topic: USP Affiliation: Education: Course Topic: USP Expert Committee Member since 2009 Company: Consultant, Clinical Microbiology Education: Ph.D., Microbiology, University of Missouri, Columbia, MO M.S., Microbiology, University of Missouri, Columbia, MO Course Topic: USP Affiliation: Education: Course Topics: Education: USP employee since 1989 Senior National Account Manager B.S., Chemistry, SUNY Albany M.S., Analytical Chemistry, SUNY Binghamton Course Topics: USP employee since 2008 Program Manager B.S., Biology, University of Texas, San Antonio HPLC; Good Laboratory Practices (GLP); Measurement Uncertainty Horacio Pappa USP Affiliation: USP Expert Committee member since 2002 USP employee since 2003 Principal Scientific Liaison Education: USP Affiliation: Biologics Overview M.B.A., Management, Our Lady of the Lake University Microbiology Laura McCurry M.A. and B.S., Biology, University of Oldenburg, Germany Regina Okafor Frederic Marsik USP Affiliation: USP employee since 2003 Vice President, Biologics and Biotechnology Ph.D., Molecular Biology, Medical University of Lübeck, Germany Ph.D., Analytical Chemistry, State University of Campinas Elemental Impurities; Analytical Method Transfer; Dissolution; USP Reference Standards; USP–NF; In-Vivo In-Vitro Correlation (IVIVC); Ophthalmic Products; Residual Solvents; Spectroscopic; Validation and Verification of Analytical Procedures; Quality Attributes of Drug Products Applied to the Skin Excipients Tina S. Morris M.Sc., Pharmacy, University of São Paulo Course Topics: B.S., Chemistry and Biology, LeMoyne College Ph.D., Inorganic Chemistry, the University of Pennsylvania M.S., University of Florida School of Pharmacy Course Topic: USP employee since 2005 Manager, Pharmacopeial Harmonization Course Topics: Ph.D., Medicinal Chemistry, University of Buenos Aires Validation and Verification; Method Transfer; HPLC; Dissolution; Spectroscopy; Chromatography; Residual Solvents; Balances; Validation and Verification of Analytical Procedures HPLC; USP Reference Standards Overview; Intro to USP–NF Doreen McDonald USP Affiliation: Education: Course Topics: USP employee since 1999 Senior National Account Manager B.A., Chemistry—Secondary Education, SUNY College at Cortland USP Reference Standards Overview; Intro to USP–NF Questions? Email Education@usp.org. 9 R Steven Paul USP Affiliation: Education: Timothy Schofield USP employee since 2004 Marketing Director B.S., Chemistry, Northern Illinois University USP Affiliation: Company: Senior Fellow, MedImmune Education: B.S., Mathematics, Lafayette College M.S., Analytical Chemistry, Northern Illinois University Course Topic: Intro to USP–NF Affiliated with USP since 2004 M.A., Statistics & Operations Research, University of Pennsylvania Course Topics: Analysis of Biological Assays; Bioassay Validation Mark Pitluck USP Affiliation: Education: USP employee since 2010 Director, USP Reference Standards USP Affiliation: B.S., Chemistry, Loyola University Ph.D., Analytical Chemistry, Marquette University Course Topic: Catherine Sheehan Education: Education: Course Topics: USP employee since 2004 Principal Scientific Liaison Ph.D., Analytical Chemistry, University of Louisville Elemental Impurities; Impurities; Pharmaceutical Stability Danica Reynaud USP Affiliation: Affiliated with USP since 2013 Company: Chief Executive Officer, Chief Science Officer, AuthenTechnologies Education: B.A., Integrative Biology, University of California Ph.D., Integrative Biology, University of California Course Topic: Doctoral Candidate in Regulatory Science, University of Southern California School of Pharmacy USP Affiliation: Affiliated with USP since 1997 Company: Consultant Education: B.Sc., Microbiology, University of British Columbia M.Sc., Microbiology, University of British Columbia Course Topic: 10 Course Topic: Bioassay Design, Development, and Validation For the latest course information, visit http://education.usp.org. Excipients John G. Shabushnig USP Affiliation: Committee Member, USP Dosage Forms Expert Chair, USP Visual Inspection Expert Panel Company: Founder and Principal Consultant, Insight Pharma Consulting, LLC Education: B.S., Chemistry, Carroll College Ph.D., Analytical Chemistry, Indiana University Course Topic: Visible Particulates in Injections Roberto Shimahara USP Affiliation: DNA-Based Botanical Authentication Methods Nancy Sajjadi M.S., Regulatory Science, Johns Hopkins University M.S., Biotechnology, Johns Hopkins University (currently pursuing) USP Reference Standards Overview Ravi Ravichandran USP Affiliation: USP employee since 2001 Senior Director, Excipients Education: Course Topics: USP employee since 2004 Director of Sales, North, South and Central America B.S., Chemistry, University of Redlands, California Elemental Impurities; Dissolution; USP Reference Standards; USP–NF; Quality Standards for Medicines 2015 Instructors Teri C. Soli USP Affiliation: Radhakrishna Tirumalai Affiliated with USP since 1989 USP Affiliation: Company: Principal Consultant, Soli Pharma Solutions Education: B.S., Microbiology, Texas A&M University Education: M.S., Microbiology, Texas A&M University Course Topic: Course Topic: Ph.D., Microbiology & Immunology, Minor, Biochemistry, University of Arizona Harry Yang Pharmaceutical Waters USP Affiliation: Erika Stippler USP Affiliation: Education: USP employee since 2007 Director, Dosage Form Performance M.S., Chemical Engineering, Babes-Bolyai University, Cluj-Napoca, Romani Ph.D., University Frankfurt Institute of Pharmaceutical Technology Course Topics: Developing and Validating Dissolution Methods; Dissolution; Performance Verification Testing (PVT); In-Vivo In-Vitro Correlation (IVIVC) Education: Senior Director, MedImmune, LLC B.S. and M.S., Applied Statistics, Peking University Ph.D., Statistics, University of Pittsburgh Course Topic: Statistics Jane Weitzel USP Affiliation: USP Expert Committee member since 2010 Member, USP Expert Committee on Reference Standards USP employee since 2011 Associate Scientific Liaison Company: Consultant Education: B.S., Chemistry (Honors), University of Manitoba B.S., Biochemistry, University of Maryland Compounding Course Topic: USP Council of Experts Physical Analysis since 2010 Company: Vice President of Development, Vitruvias Therapeutics LLC Education: Ph.D., Organic Chemistry, Emory University Organic Impurities USP Reference Standards Overview Kahkashan Zaidi Kevin Swiss Course Topic: Member, Statistics Expert Committee since 2010 Company: USP Affiliation: USP Affiliation: Microbiological Testing Member, USP Expert Panel, Method Validation and Verification Pharm.D., University of Maryland School of Pharmacy Course Topic: Ph.D., Biochemistry, University of Mysore, India Education: Jeanne Sun USP Affiliation: USP employee since 2003 Principal Scientific Liaison Education: USP employee since 1999 Principal Scientific Liaison M.Sc., Physical Chemistry, Quaid-Azam University, Pakistan M.Phil., Physical Chemistry, Quaid-Azam University, Pakistan Ph.D., Analytical Chemistry, University of Missouri, Kansas City Course Topic: Elemental Impurities Charles Tan USP Affiliation: Member of Statistics Expert Committee since 2003 Company: Director Biostatistics, Pfizer Inc Education: Ph.D., Statistics, Temple University Course Topic: Statistics Questions? Email Education@usp.org. 11 www.usp.org Headquarters 12601 Twinbrook Parkway Rockville, Maryland 20852-1790 USA Education@usp.org HEADQUARTERS Maryland, USA PE475M-2015-01 EUROPE/MIDDLE EAST/AFRICA Basel, Switzerland USP–INDIA Hyderabad, India USP–CHINA Shanghai, China USP–BRAZIL São Paulo, Brazil PQM ETHIOPIA Addis Ababa, Ethiopia CePAT GHANA Accra, Ghana 2015 Instructor Catalog