Notes from select presentations delivered at Control Strategies for Pharmaceutical Manufacturing: Real Time Release Testing and Design Space Determination have been provided below for the convenience of conference participants.
Industrial Perspective on the Use of Models in the QbD Framework
Airiau Notes
Christian Airiau, PhD
Chemometrician, Manager
GlaxoSmithKline
Statistical Methods for Establishing the Design Space and Control Within Design Space
Claycamp Notes
Gregg Claycamp, PhD
Senior Scientist, Risk Analysis and Decision Analysis
Food and Drug Administration
Case Study Strategy for Developing a New Drug Product for Real Time Release and Regulatory Requirements
Fahmy Notes
Raafat Fahmy, PhD
Science Advisor
Food and Drug Administration
Developing the Control Strategy for Pharmaceutical Manufacturing Across Scales of Manufacturing
Hoag Notes
Stephen Hoag, PhD
Professor of Pharmaceutical Sciences
Director, Good Manufacturing Practice Facility
University of Maryland School of Pharmacy
Overview of Pharmaceutical Manufacturing Control
Moore Notes
Christine Moore, PhD
Acting Director, Office of New Drug Quality Assessment
Food and Drug Administration