This unique 2 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. It will include experimental, hands-on experience of formulation development and will cover:
鈥 The product development lifecycle
鈥 Preformulation studies
鈥 Formulation development
Proper integration of all of these elements is essential to achieve "Quality by Design鈥 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.
鈥 The product development lifecycle
鈥 Preformulation studies
鈥 Formulation development
Proper integration of all of these elements is essential to achieve "Quality by Design鈥 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.