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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Attendee Presentations
2018 PDA Endotoxins Workskhop
Final Attendee List
Attendee list reflects those individuals who provided explicit consent to be included, per the General Data Protection Regulation (GDPR).
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Agenda
2018 PDA Endotoxins Workshop Final Agenda
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Lynne JL Ding, PhD
P1: rFC and Its Application (Updated)
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Jay Bolden
P1: rFC and Its Application
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Peter Bruegger
P2: Monocyte Activation Test (MAT): Considerations for Implementation in the Pharmaceutical Industry
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Ned Mozier, PhD
P2: Monocyte Activation Test (MAT): Considerations for Implementation in the Pharmaceutical Industry
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James E. Akers, PhD
P3: Depyrogenation
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Antje Hermelink, PhD
P3: Depyrogenation (Updated)
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Veronika S. Wills, MSc
P3: Depyrogenation
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Qing Joe Zhou
P4: Endotoxins and Other Immune Modulating Impurities (Updated)
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Kevin L. Williams
P4: Endotoxins and Other Immune Modulating Impurities (Updated)
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Bacterial Endotoxin Testing and Data Integrity Breakout Questions
Bacterial Endotoxin Testing and Data Integrity Breakout Questions
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Youwen Pan, PhD
Bacterial Endotoxin Testing and Data Integrity Breakouts Group A – Gel Clot Endotoxin Testing
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Breakout Questions Group A Gel Clot Endotoxin Testing FINAL NOTES
Bacterial Endotoxin Testing and Data Integrity Breakouts Group A – Gel Clot Endotoxin Testing Final Notes
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James Henderson
Bacterial Endotoxin Testing and Data Integrity Breakouts Group B – Kinetic Testing
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Breakout Questions Group B Kinetic Testing FINAL NOTES
Bacterial Endotoxin Testing and Data Integrity Breakouts Group B – Kinetic Testing Final Notes
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Scott Kaszuba
Bacterial Endotoxin Testing and Data Integrity Breakouts Group C – Automated Testing
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Breakout Questions Group C Automated Testing FINAL NOTES
Bacterial Endotoxin Testing and Data Integrity Breakouts Group C – Automated Testing Final Notes
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Friedrich von Wintzingerode, PhD
P5: Current LER Perspectives: Part 1
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Jack Levin, MD
P5: Current LER Perspectives: Part 1 (New)
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Ned Mozier, PhD
P5: Current LER Perspectives: Part 1
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Anders Thorn
P5: Current LER Perspectives: Part 2
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Mark J. Kapeckas
P5: Current LER Perspectives: Part 2
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Mark J. Kapeckas Tools
P5 Current LER Perspectives: Part 2 Tools Endotoxin Ingress Risk Assessment (EIRA) and Theoretical LER Likelihood Tool
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