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Session Chair(s)
James V. McArdle, PHD
President
McArdle & Associates LLC, United States
Speaker(s)
ICH Q9 Quality Risk Management: Perspective and Examples
H. Gregg Claycamp, PHD, MS
FDA, United States
Senior Scientist for Risk Analysis and Decision Analysis, ONADE, CVM
Applications of Risk Assessment in the Manufacturing Development Cycle
Paul Van Norman
NITTO DENKO Avecia, Inc., United States
Director, Manufacturing Operations
Paul Van Norman
NITTO DENKO Avecia, Inc., United States
Director, Manufacturing Operations
Panelist
H. Gregg Claycamp, PHD, MS
FDA, United States
Senior Scientist for Risk Analysis and Decision Analysis, ONADE, CVM
Panelist
Mohan K. Sapru, PHD, MS
FDA, United States
CMC Lead, Office of Pharmaceutical Quality, CDER
Panelist
Susann Rosmus
Biospring GmbH, Germany
Head of QM
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