New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines is a webinar dedicated to the new elemental impurities test requirements as per new ICH Q3D and USP 232/233 Guidelines, how to do risk assesment.

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines covers topics such as:

  • Regulatory status: FDA, ICH Q3D, USP 232/233
  • Elemental Impurities: The case for change
  • What drug products are within the scope of the guidance
  • Scope of the new guidance on Elemental Impurities - related to ICH Q3D and USP Chapters 232 and 233
  • How risk assessment influences what testing is required
  • Which classes of drug products need to comply with ICH Q3D and which with USP 232/233
  • Implementation of the Guidelines
  • What documentation related to control of elemental impurities is expected by FDA
  • Analytical Procedures and how methods should be validated
  • Which procedures can be used to demonstrate compliance
  • What you should be doing now?

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines intended for attendees from:

  • Laboratory Managers/ Directors / Supervisors
  • Researchers/ R&D Mangagers
  • Analytical Chemists
  • Laboratory Technicians / Operators
  • Regulatory Compliance Managers
  • Laboratory Managers
  • Chemical Manufacturing and Control managers
  • Quality Control and assurance managers

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