Extractables, Leachables, & Elemental Impurities 2017 – West Coast

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Ensuring Quality, Safety, and Regulatory Compliance for Drugs & Biologics

With Representation From:

• Pfizer
• Allergan
• Amgen
• Janssen
• Lilly
• Sanofi
• Shire
• Aspen Research
• Pall
• Jordi Labs
• Eurofins
• West Pharmaceutical Services
• Agilent
• Amri Global
• VR Analytical
• Material Needs Consulting
• Triad
• Eakins & Associates
• Knoell
• Nitto Avecia Pharma Services

Featuring Comprehensive Coverage On:

• Updates & Case Studies on the Latest Compliance Implications of USP and ICH Q3D Risk Assessment Filing Guidelines for Elemental Impurities
• The Risk Assessment of Extractables – A Toxicological Window of Opportunity
• BPOG’s Leachables Best Practice Guide: Study Design and Analytical Methods
• Challenges & Consequences for the Medical Device Industry by the Revision of Three Major ISO 10993 – Standards
• Extractables Screening of Polyproylene Resins for the Identification of Suitability for Use Hazards
• Maximizing E/L Studies Through Harmonization of USP & ISO 10993
• Leachable Risk Assessment of Dosing Devices for Parenteral Applications
• Extractables & Leachables Studies on Single-Use Components in Biomanufacturing
• Addressing Challenges with Polysorbate 80
• E&L Test Methodologies for Lyophilized Drug Products
• Industry Working Group Updates: PQRI & BPOG
• And More!