Pharma Training Services, Radisson SAS Hotel, Cork, Ireland
2009/04/28 - 30
This unique 3 day course introduces and integrates the key elements of tablet development based on the principles of Quality by Design (QbD) set out in ICH Q9:
- Preformulation studies
- Formulation development
- Process development and validation
and explains the important links between each of these. Proper integration of these elements is essential to achieve “Quality by Design” because data from each phase of development 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. Key process parameters and their control are identified.
RELEVANT TO: The course is designed for people new to tablet and process development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why processes can go wrong, and regulatory and quality personnel who need to understand the development process.