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QbD Viewpoint
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Turn data into actionable product and process understanding:

  • Extract product and process understanding from low-value, multi-dimensional data
  • Obtain additional return on past project data that the organization has already paid for
  • Reuse product and process understanding across functions in future projects
  • Work smarter by building predictive models for better decisions

Reduce time-to-decision and cost of process-understanding:

  • Leverage pre-existing data from past development projects
  • Reduce number of experiments using adaptive design
  • Streamline decision making by putting scientists in control
  • Improve productivity by automating data analysis and reporting

Provide a vehicle for enterprise deployment of Quality-by-Design initiatives:

  • Built on top of easy-to-use Microsoft Office, already implemented by most organizations
  • Standardize identification and application of critical process parameters and design space
  • Enable collaboration, content management, searching, security and application integration
  • Achieve compliance with FDA requirements and guidelines including Q8 and 21 CFR 11
 

 QbD Viewpoint

1/29/2008 by Paul van Eikeren
The International Foundation Process Analytical Chemistry (IFPAC) completed the first day of their 22nd International Forum on Process Analytical Technology covering a full cross-section of subjects focused on the application of Process Analytical Technology to QbD ...
 
1/28/2008 by Paul van Eikeren
The FDA has recognized that product development is now the weak link in the “critical path” from scientific discovery to commercial product. In response, the FDA has instituted ...
 
12/13/2007 by Paul van Eikeren
According to findings of the largest empirical study ever performed on the interplay of pharmaceutical manufacturing and the Food and Drug Administration (FDA), the pharmaceutical industry is wasting more than $50 billion ...
 

 

 Getting Started

For more information about Inference for QbD, please click below to view the 2-minute Overview Screencast:
 
 
 
Additionally, you can download and read the Inference for QbD Product Tour PDF document below:
 
 
Finally, for more information about evaluating Inference for QbD, please contact us at:
 
 

 

 What's New

Blue Reference joins BioIT Alliance 
by Windows SharePoint Services Admin
 5/12/2008 5:55 PM
 
NSF Supports Further Development of Inference for QbD Software 
by Paul van Eikeren
 3/20/2008 12:43 AM
 

 
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