INFORMAÇÕES DO CURSO
Visão Geral do Curso:
This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to impurities in monographs. It also provides insights to USP‒NF General Chapters <476> and <1086> and include case studies for impurities in the development and revision of USP monographs.
Ao finalizar este curso você será capaz de:Discuss the origin and classification of impurities in pharmaceuticals;Explain global guidance’s for impurities;Describe the USP approach to impurities in drug substances and drug products;Discuss the USP general chapters on impurities;Explain the USP approach to harmonization across pharmacopeia;Demonstrate knowledge of USP’s approach for impurities in documentary standards via case studies.
A quem se destina:Analytical scientists;QA/QC;Formulators;Manufacturing scientists;CMC submission and review scientists;Regulatory professionals.
Ravi Ravichandran Ph. D
Principal Scientific Liaison, Science-Chemical Medicines
Ph.D. in Analytical Chemistry , University of Louisville
Dr. Ravichandran has been employed at USP since 2004. In this role as a scientific liaison, he has been supporting the Expert Committees involved in the introduction and revision of documentary standards for psychiatric drugs, inhalation products and radioactive drugs and contrast imaging agents. He provides support to the Chemical Medicines four Expert Committees. Ravi has over 35 years of experience in both industry and government.
Dr. Ravichandran’s industrial experience includes several years in the diagnostics and pharmaceutical industry where he gained experience in analytical methods development for both raw materials and finished product characterization, methods and technology transfer to manufacturing sites, and QC laboratory management. Dr. Ravichandran received his Ph.D. in Analytical Chemistry from the University of Louisville, Louisville, KY. He had a subsequent postdoctoral appointment at the University of Georgia, where he worked with Dr. L.B (Buck) Rogers in the area of separations. He has several publications including review articles in peer-reviewed journals and has also written book chapters. In 1999/2000, Ravi served as the President of the Minnesota Chromatography Forum. He is actively involved in Washington Chromatography Discussion Group in MD.
On Demand - Faça conforme sua disponibilidade de tempo.
INVESTIMENTOInscrição: R$745,00 (aprox. US$149,00)
O acesso a este treinamento é pessoal, intransferível e concede para um único aluno o direito de visualizar esta transmissão e obter um certificado. Compartilhar esta transmissão com pessoas não inscritas durante ou após sua apresentação viola os direitos autorais da USP e é proibido.O acesso será liberado automaticamente assim que o pagamento for confirmado pela operadora.Este treinamento dá direito à emissão de Certificado de Conclusão.