This webinar is designed to provide a comprehensive 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. Topics for discussion include general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities.
Who Will Benefit:
Chemists (Research, Quality Control, and CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.
- 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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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.