PQRI/USP Workshop on Elemental Impurity Requirements in a Global Environment – Next Steps?

March 31 – April 1, 2015 - USP Meeting Center

Rockville, Maryland


The time to finalize implementation plans is now! This workshop will provide practical solutions tochallenges involved in global implementation of the Elemental Impurity (EI) guidelines andstandards. Specific topics will include the following:


• Assessment of Ingredients – Excipients & APIs

• Analytical Testing Considerations

• Successful Risk Assessment Methodologies

• Finished Dosage Form Considerations

• Implementation Strategy

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