2017 PDA Endotoxins Workshop

Attendee Presentations

2017 PDA Endotoxins Workshop

Program Agenda

Program Agenda

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Jack Levin, MD - Presentation Not Authorized for Distribution

P1: Opening Plenary: Academic Perspectives on the Limulus Amebocyte Lysate Assay, Endotoxin Structure, and Diversity

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M. Stephen Trent, PhD - Presentation Not Authorized for Distribution

P1: Opening Plenary: Academic Perspectives on the Limulus Amebocyte Lysate Assay, Endotoxin Structure, and Diversity

(?)
Maria “Reyes” Candau-Chacon, PhD

P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors

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Amber Dellar

P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors

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John A. Dubczak

P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors

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Douglas W. Stearn, JD

Breakfast Session: Data Integrity

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Malcolm A. Finkelman, PhD

P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety

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Christine Schubert, PhD

P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety

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Jay Bolden

Group A – Case Study 1: Setting Endotoxin Specifications

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Friedrich von Wintzingerode, PhD

Group B – Case Study 2: Setting in-Process Endotoxin Limits

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Ned M. Mozier, PhD

Small Group Discussion: Pyrogen Test Comparison

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Ingo Spreitzer - UPDATED

Small Group Discussion: Pyrogen Test Comparison

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Small Group Discussion Questions

Small Group Discussion: Pyrogen Test Comparison

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John A. Dubczak

P4: BET Laboratories: Practical Advice

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Veronika Wills, MSc

P4: BET Laboratories: Practical Advice

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Attendee Presentations

2017 PDA Endotoxins Workshop

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