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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
2017 PDA Endotoxins Workshop
Program Agenda
Program Agenda
(?)
Jack Levin, MD - Presentation Not Authorized for Distribution
P1: Opening Plenary: Academic Perspectives on the Limulus Amebocyte Lysate Assay, Endotoxin Structure, and Diversity
(?)
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
(?)
Amber Dellar
P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors
(?)
John A. Dubczak
P2: Practical Issues with Endotoxin Testing and Regulatory Responsibilities of Sponsors
(?)
Douglas W. Stearn, JD
Breakfast Session: Data Integrity
(?)
Malcolm A. Finkelman, PhD
P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety
(?)
Christine Schubert, PhD
P3: Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing, Effects on Bacterial Endotoxin Testing, and Potential Impact on Patient Safety
(?)
Jay Bolden
Group A – Case Study 1: Setting Endotoxin Specifications
(?)
Friedrich von Wintzingerode, PhD
Group B – Case Study 2: Setting in-Process Endotoxin Limits
(?)
Ned M. Mozier, PhD
Small Group Discussion: Pyrogen Test Comparison
(?)
Ingo Spreitzer - UPDATED
Small Group Discussion: Pyrogen Test Comparison
(?)
Small Group Discussion Questions
Small Group Discussion: Pyrogen Test Comparison
(?)
John A. Dubczak
P4: BET Laboratories: Practical Advice
(?)
Veronika Wills, MSc
P4: BET Laboratories: Practical Advice
(?)
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