A schedule of events for Control Strategies for Pharmaceutical Manufacturing: Real Time Release Testing and Design Space Determination is provided below for your convenience.
This one-day conference scheduled for Thursday, May 23, 2013, at the University of Maryland School of Pharmacy is open to the public. For a printable agenda, please download the conference brochure.
| Time | Presentation |
|---|---|
| 10:00-10:10 a.m. | Meeting Overview Stephen Hoag, PhD Professor of Pharmaceutical Sciences Director, Good Manufacturing Practice Facility University of Maryland School of Pharmacy |
| 10:10-10:40 a.m. | Overview of Pharmaceutical Manufacturing Control Christine Moore, PhD Acting Director, Office of New Drug Quality Assessment Food and Drug Administration |
| 10:40-11:20 a.m. | Case Study Strategy for Developing A New Drug Product for Real Time Release and Regulatory Requirements Raafat Fahmy, PhD Science Advisor Food and Drug Administration |
| 11:20-12:00 p.m. | Developing the Control Strategy for Pharmaceutical Manufacturing Across Scales of Manufacturing Stephen Hoag, PhD Professor of Pharmaceutical Sciences Director, Good Manufacturing Practice Facility University of Maryland School of Pharmacy |
| 12:00-1:00 p.m. | Lunch Will Be Provided |
| 1:00-1:40 p.m. | Statistical Methods for Establishing the Design Space and Conrol Within Design Space Gregg Claycamp, PhD Senior Scientist, Risk Analysis and Decision Analysis Food and Drug Administration |
| 1:40-2:20 p.m. | Industrial Perspective on the Use of Models in the QbD Framework Christian Airiau, PhD Chemometrician, Manager GlaxoSmithKline |
| 2:20-3:00 p.m. | Industry Experiences in Launching, Managing, and Transferring A Real-Time Release Testing Method Globally from 2006 to Today Gert Thurau, PhD Director, Process Analytical Technology (PAT) Merck |
| 3:00-3:15 p.m. | Break |
| 3:15-4:00 p.m. | Speaker Breakout Session Discussion of Key Issues:
|