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Improving Processes and Delivering Business Benefits Through QbD: Milling of an API

Posted: 08/02/2010

 

What are the 7 Deadly Sins of Quality Assurance and Quality Control?
Download our free QA QC eBook now to find out!




Tags:   Michael Juhnke | QbD | PAT | DoEs | PAT implementation | Quality by Design

In this case study: An outline of the QbD strategy applied to a marketed drug product; using quality risk management tools, DoEs and PAT tools at pilot and full scale; confirmation of the design space and control strategy for real time release at full scale and process improvements by applying QbD.

Presented by Dr. Michael Juhnke, Principal Scientist, Technical Research and Development, Novartis Pharma AG, at IQPC's 6th Annual PAT and Quality by Design.


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