Extractables, Leachables & Elemental Impurities 2018

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

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, and parenteral drug products. 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.

With Representation From:

• FDA
• Johnson & Johnson
• Pfizer
• Merck
• Eli Lilly & Co
• Sanofi
• Pall
• Jordi Labs
• Agilent
• West Pharmaceutical Services
• EKG Labs
• Almac
• VR Analytical
• Toxikon
• SGS
• Triad
• Material Needs Consulting
• Intertek
• Akorn Pharmaceuticals

Featuring Comprehensive Coverage On:

• Key Issues in Satisfying ICH Q3D, and USP Guidelines Regarding Elemental Impurities (EI)
• Update on revised USP for Materials and Components used in Pharmaceutical Manufacturing Systems
• Update on Revision of USP, for Plastic Material Components and Packaging Systems
• Update on revised USP for EI and Extractables for Elastomeric Enclosures in Injectable Devices
• Analytical Challenges in Extractable and Leachable Studies of Pre-Filled Syringes for Oil-Based Drug Formulations
• PQRI Thresholds and Best Practices for E&L for Biologics
• Designing and Improving Risk-Based Assessment of E&L Data for Drugs, Biologics, and Medical Devices
• E&L Considerations in the Qualification and Validation of Single-Use Systems
• Toxicology Assessment Approaches for E&L Studies
• E&L for Oral Dosage Forms
• Addressing Extractables & Leachables from Bioprocessing Equipment & Product Packaging
• And More!