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This 2-hr webinar will provide a comprehensive overview of impurities in pharmaceutical products, that require to be controlled, and the strategies for controlling them. Why Should You Attend: This webinar is designed to provide an overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. We will discuss drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities and general impurities (not structurally related to the drug substance), such as residual solvents and elemental impurities. Areas Covered in the Seminar: - Overview of Impurities in Pharmaceutical Products Requiring Control
- Drug Substance Impurities (ICH Q3A)
- Drug Product Impurities and Degradation Products (ICH Q3B)
- Potential Genotoxic Impurities (FDA Guidance 2008 and EMEA Guidance 2006)
- Residual Solvents (USP <467>)
- Elemental Impurities (USP <231, 232, 233>)
- Drug Related Impurities
- Process Impurities
- Chromatographic tests
- System suitability tests
- Degradation Products
- Forced Degradation Studies
- Chromatographic tests
- System suitability tests
Who Will Benefit: - Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products
- Quality assurance or regulatory affairs personnel responsible for review or reporting of data for drug substances or drug products
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