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This webinar will provide excipient users (pharmaceutical companies, contract manufacturers, and other interested stakeholders) with practical advice and information necessary in order to conduct an elemental impurity risk assessment and ultimately assure compliance with the requirements of ICH Q3D. Sourcing of the needed data and information from excipient and other suppliers, the literature, and internal test results and databases will be discussed. The presenter will also cite examples from his own experience with ICH Q3D, USP, and EP compliance and involvement with industry groups dealing with these issues.
Upon completion of this webinar, the participant should be able to:
- Describe the key ICH Q3D, USP and EP elemental impurity requirements as they apply to finished dosage forms
- Explain the process for performing a risk assessment to determine and justify permitted daily exposure (PDE) calculations for elemental impurity limits in finished dosage forms
- Identify several sources of published elemental impurity data and understand how such data may form part of an overall risk assessment