Event Date/Time: Apr 07, 2011 End Date/Time: Apr 08, 2011
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This course will include experimental, hands-on experience of formulation development:
The Product Development Lifecyle
* Making sense of ICH Q8, 9 and 10
* Identifiying the material properties which will become Critical Quality Attributes at an early stage
Preformulation studies:
* Material characterisation
* Morphic form identification Salt selection
* Compressibility testing
* Excipient and Process compatibility testing
* Applications of advanced techniques to aid development including AFM
Formulation development:
* Formula selection
* Process selection
* Product Optimisation and the formulation cycle
* Advanced Intermediate and Product characterisation
* Develping Product Control Strategies at the formulation development phase
Proper integration of all of these elements is essential to achieve “Quality by Design” because data from each phase is used to control the next step in the development process. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided.

The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed step by step analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific learning in this participative course.