The goal of this workshop is to provide detailed information on the implications of Quality by Design (QbD) for the validation and qualification of tablet manufacturing processes and process development. We will also review the principles of PAT for tablets and capsules and their implications for process control, and introduce important new concepts including the use of risk and process matrices for risk management
By the end of the course, you will understand the relationship between QbD principles and tablet development and process validation, understand the processes commonly used to manufacture tablets and capsules, and the factors which affect them, recognise how to identify critical processing parameters, and how to incorporate into a process validation program and understand the principles of PAT, how and where it can be most effectively deployed
Who should attend
Tablet formulation and process development staff and those involved in managing process development and validation, and commissioning products into production. Regulatory Affairs staff preparing dossiers for tablet products. Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols. Numbers will be limited to give participants the opportunity for thorough discussion of the issues to be covered by the programme and one on one consultation with speakers.
By the end of the course, you will understand the relationship between QbD principles and tablet development and process validation, understand the processes commonly used to manufacture tablets and capsules, and the factors which affect them, recognise how to identify critical processing parameters, and how to incorporate into a process validation program and understand the principles of PAT, how and where it can be most effectively deployed
Who should attend
Tablet formulation and process development staff and those involved in managing process development and validation, and commissioning products into production. Regulatory Affairs staff preparing dossiers for tablet products. Quality Assurance personnel responsible for the design or implementation of tablet process validation protocols. Numbers will be limited to give participants the opportunity for thorough discussion of the issues to be covered by the programme and one on one consultation with speakers.
