This unique course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD), with a particular focus on low cost manufacturing formulas and processes.
Topics include:
•Applying Quality by Design at the development phase
•Relating drug substance properties to desired formulation characteristics
•Development formula and process"how these are linked
•Identifying tablet formulas and processes which will minimise development and manufacturing costs
•Optimising formulations to maximise throughput and minimise cost
•Developing the Product Control Strategy"Critical Quality Attributes and Critical Process Parameters"with a focus on cost reduction.
Selection of the optimal manufacturing process for a particular AMP can have a dramatic effect on subsequent production costs.
The course includes case studies of tablet formulation development and a detailed analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific learning in this participative course.
Topics include:
•Applying Quality by Design at the development phase
•Relating drug substance properties to desired formulation characteristics
•Development formula and process"how these are linked
•Identifying tablet formulas and processes which will minimise development and manufacturing costs
•Optimising formulations to maximise throughput and minimise cost
•Developing the Product Control Strategy"Critical Quality Attributes and Critical Process Parameters"with a focus on cost reduction.
Selection of the optimal manufacturing process for a particular AMP can have a dramatic effect on subsequent production costs.
The course includes case studies of tablet formulation development and a detailed analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific learning in this participative course.
