Quality by Design (QBD)

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Event Date/Time: Feb 08, 2011 End Date/Time: Feb 09, 2011
Registration Date: Feb 08, 2011
Early Registration Date: Dec 23, 2010
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Description

Preliminary Program Outline

Impact of Quality by Design on Regulatory GMP Inspectional Practices
Quality by Design (QbD): A Framework for Success
Filing a QbD Submission
Why QbD?
Application of PAT in Drug Development
Using QbD Principles and PAT to enable Real-Time Release Testing (90 min)
Building Quality – From API to Finished Product
Experimental Strategies for Implementing Quality by Design
Building Data-Based Knowledge and Skills Needed to Implement Quality by Design
Strategies for Developing Multi-Component Formulations
Effective Data Processing: Using QbD to Improve Process and Product Understanding
Implement QbD in a Quality Organization
Concepts of Process Variation about a Target and It’s Role in Quality by Design
Basic Concepts and Issues in Modeling Process Variation and Parameter Uncertainty”
Using QbD Approaches to Enable Development of Real-Time-Release for a Continuous Drug Product Process
Application of QbD for Biopharmaceuticals (Workshop – 3 hrs.)
The Future of QbD
Applying QbD Concepts to Improve Both Method Validation and Transfer
QbD Approach in Pharmaceutical Development
ICH Q8 – Design Space Concept
Building Design Space and Control Space in QbD
The Relation Between QbD, Risk Assessment, Design Space, Control Strategies and Process Validation
Quality by Design in the CMO Environment
Design Space for Biotech Products

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