Extractables, Leachables, & Elemental Impurities 2014

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

Featuring Representation From:

• FDA
• USP
• Merck
• Eli Lilly & Co.
• Janssen R&D-A Pharmaceutical Company of Johnson & Johnson
• NSF Health Sciences
• Boehringer Ingelheim
• Bausch+Lomb
• BD
• Aspen Research Corporation
• West Pharmaceutical Services
• Baxter Healthcare Services
• Forest Laboratories
• Novo Nordisk
• Fresenius Kabi
• Exova
• Toxikon
• Eakins & Associates
• Material Needs Consulting

Attention to leachables, extractables, and elemental impurities has increased due to the recent revisions of EMA, 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. In addition, we will also focus closely on the keys to satisfying recent ICH, USP, and EMA guidelines for metal impurities in current and future drug products and biologics.

Featuring Comprehensive Coverage On:

• Meeting Qualification and Compliance Implications of USP <232> and <233>, ICH, and EMA Guidelines for Elemental Impurities
• Industry Working Group Update: The PQRI Leachables and Extractables Considerations for Parenteral and Ophthalmic Drug Products
• Total and Extractable Elemental Impurities In Plastic Materials and Systems: A Literature Review
• Analysis of Extractables & Leachables: Past, Present and Future Trends
• Extractable Study Design and Data Evaluation of Polymeric Product Materials
• Safety Assessment of Leachables for Parenteral Drug Products
• Extractables & Leachables from Infusion Pump Systems
• Managing the Risks of Leachables from Single-Use Processing Equipment
• Use of Simulation Studies to Support Change Control in Ophthalmic Packaging Systems
• Extractables & Leachables Considerations in the Qualification and Validation of Single-Use Systems
• E/L Studies for Me
• dical Devices Based on Blood Separation Technologies
• And Much More!