This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed.
By the end of the course, you will -
* Understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development
Understand the relationship between material properties, formulation development and process development
* Understand the processes commonly used to manufacture tablets and the factors which affect them
Recognise how to identify critical processing parameters, and how to incorporate into a process validation program
* Understand the principles of PAT, how and where it can be most effectively deployed
Know the latest FDA thinking on Process Development including the three key steps of validation
Who should attend?
The course is designed for people new to Process Development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process better.
The course will include the latest FDA guidance on the development of generic products under QbD.
By the end of the course, you will -
* Understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development
Understand the relationship between material properties, formulation development and process development
* Understand the processes commonly used to manufacture tablets and the factors which affect them
Recognise how to identify critical processing parameters, and how to incorporate into a process validation program
* Understand the principles of PAT, how and where it can be most effectively deployed
Know the latest FDA thinking on Process Development including the three key steps of validation
Who should attend?
The course is designed for people new to Process Development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process better.
The course will include the latest FDA guidance on the development of generic products under QbD.
