Safety Evaluation on Extractables and Leachable
 Dr. Clemens Guenther, Director Senior Expert Nonclinical Safety, Bayer AG
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Extractable and Leachable Analysis:
Identification and semi quantitation workflows using Mass Spec
 Chander Mani, Application Engineer, Agilent Technologies
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PQRI Best Practices: Use of a Classification Strategy to Develop Safety Thresholds
 Dr. Daniel Norwood, Principal Consultant, Feinberg Norwood & Associates Pharma Consulting
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Analytical Updates and Sample Preparation in Extractable and Leachable Profiling Types of Impurities
 Dr. Atish Sen, Staff Scientist, Analytical Sciences - Inhalation Product Development, AstraZeneca
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Extractables and Leachables: Regulations and Strategies for OINDPs
Dr. Daniel Norwood, Principal Consultant, Feinberg Norwood & Associates Pharma Consulting
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ICH Q3E Impurity Guideline: Assessment and Control of Extractables and Leachables for Pharmaceuticals and Biologics
 Jason Creasey, Managing Director, Maven E&L Ltd.
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Implementation and Validation of Single Use Technologies
 Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and Validation Consulting group, Pall Biotech
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A Framework for Understanding Leachables Risk Management
 Dr. Lee Nagao, Senior Director of Science, Regulation and Policy, Faegre Drinker, Biddle and Reath, LLP
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Using GC & LC Orbitrap Mass Spectrometry to Confidently Identify Leached Packaging and Process Impurities
 Dominic Roberts, Product Marketing Manager – GC & GCMS, Thermo Fisher Scientific
 Kate J. Comstock, Senior Pharmaceutical Products Manager, Thermo Fisher Scientific
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The Use of Solid Phase Microextraction in Extractables & Leachables Studies
 Dr. Roger Pearson, President Analytical Services
Aspen Research Corporation
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Challenges in leachable method development and validation
 Dr. Andrew Feilden, European E&L Strategic Director, Hall Analytical
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Are your materials ready for use as primary packaging and medical devices ?
 Dr. Carsten B. Senholt, Partner & CTO, SAXOCON
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Importance of Accurate Chemical Characterization of Medical Devices Extractables
 Dr. Ron Brown, Toxicologist, Risk Science Consortium and Former FDA
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Toxicological Risk Assessment of Extractables & Leachables
 Dr. William Beierschmitt, Managing Partner & Toxicology Expert, D&B ChemTox, LLC
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