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During this course the principles and key aspects of Quality by Design will be discussed. You will learn
How to identify Critical Quality Attributes
How to design an effective risk based control strategy
How to provide QbD related information in a regulatory submission
How Process Analytical Technology can be applied as part of a control strategy
In an interactive workshop provides the opportunity to elaborate criticality analyses for various API syntheses.
In many cases the synthesis of small molecule APIs is achieved by using multiple intermediates which themselves are produced using different processes. To ensure the API manufacturing process consistently delivers an API meeting its specifications each of these processes needs to be robust.
The Quality by Design approach aims to scientifically determine product and process characteristics derived from criteria set after analysis of the intended drug application.
These product characteristics, the so called critical quality attributes (CQAs), must be identified and in the next step the critical process parameters (CPPs) have to be
Suitable approaches to identify these parameters are design of experiments (DOE) or general risk assessments e.g. FMEA. When linked to each other the CQAs and CPPs define the range within the process is considered to be robust.
This has to be demonstrated by a compilation of the relevant information in the application dossier.
This course is designed for all persons which are
involved in the manufacture of APIs especially in process development, process validation, scale-up and transfer and CMC dossier preparation. Furthermore, the seminar will be of interest to personnel from quality assurance, regulatory affairs both from API and pharmaceutical companies and to contract manufacturers.
In this workshop delegates will elaborate criticality analyses of different APIs. As part of this analyses critical quality attributes and critical process steps within the synthesis of the APIs will be identified.
General framework and key elements of QbD for APIs – background and potential strategies