Extractables, Leachables, & Elemental Impurities

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Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of USP and ICH guidelines. This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical industry, including drug packaging and delivery components, single-use systems, parenteral drug products, and infusion pump systems. We will hear from key industry working groups such as PQRI and BPOG. In addition, we will focus closely on the keys to satisfying recent ICH and USP guidelines for metal impurities in current and future drug products and biologics.

Featuring Comprehensive Coverage On:

• Updates & Case Studies on the Latest Compliance Implications of USP and ICH Guidelines for Elemental Impurities
• Development and Justification of a Risk Evaluation Matrix to Guide Testing Necessary to Select and Qualify Plastic Components used in Production Systems for Pharmaceutical
• Systematic Extractable Risk Assessment of Polymeric Product Contact Materials in the Manufacturing and Packaging of Biologics
• Materials Characterization and Extractables and Leachables: Designing and Executing Studies
• Safety Assessment of Leachables
• Managing the Risks of Leachables from Single-Use Processing Equipment
• Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
• An Approach for E&L Evaluations of High Risk Infusion Devices
• Practical Approaches for Extractables/Leachables Study and Toxicological Assessment for Printing Inks for Large Volume Parenteral Drug Products
• And Much More!