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Home > All Products > Understanding the Challenges Behind QbD - A Review of Leading Practices
Understanding the Challenges Behind QbD - A Review of Leading Practices
List Price: $398.00
Price: From $298.00 to $1,200.00
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This web seminar CD provides you with an overview of the CRADA Research Study Conformia has been conducting with the FDA. Our presenters provide their findings which begin to address how companies are working to implement the key QbD concepts within development operations. You will review key findings from the Study while also identifying key best practices that have emerged from the Research Study itself.
You will walk away with a better understanding of not just what QbD is but also, a clear idea of what their own firms should think about as their own QbD Programs are put into place. By reviewing the findings, you will have the opportunity to measure their own practices against the findings reviewed and see what steps their organizations should consider taking to make sure they are positioned to take advantage of the benefits QbD has to offer.
You will learn:
· How to think about existing QbD programs
· Key best practices from a CRADA Research Study
· How to leverage the benefits of QbD
Who will benefit:
You will benefit from this material if you are from the biotech or pharmaceutical industry with responsibilities or involvement in the following areas:
Regulatory Affairs
QA/QC/IPC
Development
Manufacturing Operations
Engineering
Validation
Pharmaceutical and Process Development
Chemical, Biochemical and Synthesis Development
Analytical Development
Manufacturing
Quality Management
Validation/Qualification Managers
About Our Presenter:
Sam Venugopal
Director
Conformia Software’s Life Science Operations
Sam Venugopal has over 15 years of management consulting, market research, and technical experience with companies that include Pittiglio Rabin Todd & McGrath (PRTM). At Conformia, Mr. Venugopal currently co-investigator on a Cooperative Research and Development Agreement (CRADA) with FDA, which is examining the root causes of drug development bottlenecks. |
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