Extractables & Leachables Boston 2019

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Ensuring Quality, Safety, Suitability and Regulatory Compliance for Drugs, Biologics and Medical Devices

This two-day conference will examine the safety, quality, and regulatory issues involved in a wide array of contexts central to the pharmaceutical and biotech industries, including drug packaging and delivery components, single-use systems, medical devices, and parenteral drug products. In addition, we will focus closely on the keys to satisfying recent revisions to several applicable USP chapters and the recently revised standards contained in ISO 10993.

Featuring In-Depth Coverage On:

• The Ongoing Development of USP Chapters and Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems
• Issues Frequently Observed in Analytical Evaluation of Leachables in Drug Products (An FDA Review Experience)
• Toxicological Risk assessment of Medical Device Constituents-The New Working Draft of ISO 10993-17
• Understanding the Major Revisions to ISO 10993 and the New European Medical Device Regulations
• ISO 10993-18: Chemical Characterization of Medical Devices
• Application of ISO 109993-12 Exhaustive Extraction to Support Biocompatibility of Implantable Devices
• Exploring Biocompatibility Vs. Chemical Assessment in E&L Study Design
• Revisiting the PQRI/USP Identification Categories for Leachables and Extractables
• The Use of Simulation Extractions to Address Leachables for Single Use SystemsExtractable and Leachable Evaluation for Complex Pharmaceutical Formulations
• The Proper Use of Extractables Data – Aspects Beyond Extractables Measurement
• Advanced Identification Methods for E/L from Packaging & Manufacturing Components
• Understanding Leaching Associated with Lyophilized Drug Products Stored in Vial/Stopper Packaging Systems

With Representation From:

• FDA
• PPD
• Sartorius Stedim
• VR Analytical
• Fresenius Medical Care
• Intertek
• Med Institute
• Triad Scientific Solutions
• Nitto Avecia
• Knoell Germany GmbH
• Material Needs Consulting
• Smithers
• Exova
• Eakins & Associates
• Risk Science Consortium
• SGS