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Active Pharmaceutical Ingredient (API) and Drug Product Specifications

11-12-2013  - 13-12-2013

This continually updated course covers the entire gamut of operations in the development of a New Chemical Entity (NCE) - from discovery to the filing of a New Drug Application. Emphasis will be placed on discussing stability issues, impurity profiles, polymorphism, bioequivalence, ...

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1-day Anthias AMDIS Basics course

12-12-2013  - 12-12-2013

This 1-day classroom based course teaches you the theory of how to use this powerful Automated Mass Spectral Deconvolution and Identification System software to process your GC-MS data through presentations and demonstrations by the course instructor. If you need to understand how ...

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Writing Effective Standard Operating Procedures and Other Process Documents

12-12-2013  - 13-12-2013

This course presents a comprehensive overview of process writing that the binding regulations require. There’s a tenet among regulatory bodies: “If you didn’t write it down, it didn’t happen,” and while the regulations tell companies what they need to do and document, they don’t tell them ...

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