Addressing Impurities in Pharmaceutical Products: Impurities, Degradants, Residual Solvents and Elemental Impurities 2012

Key Topics

• Drug Related Impurities
  
  • Degradation Products
  • Process Impurities
  • Establishing specifications
  • Potential Genotoxic Impurities
• Overview of Impurities in Pharmaceutical Products Requiring Control
  
  • Drug Product Impurities and Degradation Products (ICH Q3B)
  • Drug Substance Impurities (ICH Q3A)
  • Residual Solvents (USP 467)
  • Potential Genotoxic Impurities (FDA Guidance 2008 and EMEA Guidance 2006)
  • Elemental Impurities (USP 231, 232, 233)
• General Impurities
  
  • Elemental Impurities
  • Residual Solvents

Who should Attend

• Quality assurance or regulatory affairs personnel responsible for review or reporting of data for drug substances or drug products
• Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products