Quality by Design (QbD)

Venue: Holiday Inn Somerset

Location: Somerset, New Jersey, United States

Event Date/Time: Oct 19, 2009 End Date/Time: Oct 20, 2010
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Description

An Important, Two Day Conference with Discussions and Case Studies
Quality by Design - Introduction and Regulatory Perspective
Implementing a Quality by Design (QbD) Program that Makes Process Validation a Lifestyle
QbD activities within FDA
Quality System Design Control Approach to New Drug Development
The business benefits and practical user requirements for QbD
QBA and Elements of QbD
Making the Business Case for ‘QbD’
ICH Q8/Q9/Q10/Q11
Current State of API manufacturing
Exploitation of QBA Elements for a Batch/Continuous Process
Examining the Novartis/FDA CRADA QbD project
QbD/PAT Implementation: From Science to Compliance
Background and Chanllenges
Implementation and Sustainability
Applying Process Analytical Technology and Continuous Manufacturing to existing commercialized pharmaceutical products
Application of QbD Tools in the Development of Pharmaceutical Products
QbD Strategy developed by Wyeth
Real world examples of risk management and scientific tools
Best practice for successful QbD filing applications

Venue

195 Davidson Avenue
Somerset
New Jersey
United States
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