This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Quality needs to be built in to the product at design stage. So, we will discuss in detail about this quality by design concept and further technology transfer practices. We will focus on practical approach for developing the product as well as analytical methods and their successful technology transfer in the plant.
This will help you all to be ready and free from any product related problems in future. Or in case of any problems in future, your development and technology transfer team can have ready pragmatic solution on it. We will focus on how ICH Q8 can be used in line with ICH Q9 and ICH Q10. So that, the pharmaceutical quality system will enable the quality product at design stage only and ensure continuous improvements.
– Regulatory background and benefits of QbD
– Quality Risk Management (QRM) (process and tools e.g. FMEA, risk ranking)
– Designing the Control Strategies
– PQS & GMP and their link to Control Strategies
– Design of Experiments
– Developing a Design Space
– Process Analytical Technology (PAT)
– The importance of technology transfer
– The use of a technical review and Product Strategy Review systems
– Tools and Templates used for technology transfer
– Analytical Testing, Validation, Transfer