This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work.
The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).
Who Should Attend?
* Newcomers to tablet formulation development and manufacturing
* Production operators who need a better understanding of their products and how they have been developed
* Analytical and QC staff who would benefit from understanding the tablet development and production process
* Experienced personnel in one area of product development who need a broader overview
* Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
* Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers.
* Regulatory agency staff requiring practical experience
Numbers are restricted for maximum benefit
Learning outcomes
* Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
* Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
* Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development
The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).
Who Should Attend?
* Newcomers to tablet formulation development and manufacturing
* Production operators who need a better understanding of their products and how they have been developed
* Analytical and QC staff who would benefit from understanding the tablet development and production process
* Experienced personnel in one area of product development who need a broader overview
* Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
* Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers.
* Regulatory agency staff requiring practical experience
Numbers are restricted for maximum benefit
Learning outcomes
* Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
* Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
* Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development
