Quality by Design (QbD) concepts are becoming the defacto best practice spearheaded by the FDA and EMA. But how can you implement ICH Q8-Q11 with confidence for small molecules and biotech products?
As part of our Chemical Manufacturing series, DIA brings together expert faculty from Regulatory agencies, academia and industry. ICH and DoE expertise will accompany you to building a practical knowledge base.
METHODOLOGY & OUTCOMES
By the end of this 2.5-day course, you will have enough knowledge and reference points to establish a Design Space and essential elements of the Control Strategy. Through a series of case studies you will learn how to use Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management (KM).
Case scenarios include:
- solid dosage form of a small molecule
- manufacturing process for a biotech product
You will learn how to prioritise the potential critical formulation and process parameters with QRM, propose, execute and evaluate a DoE to define the critical parameters and eliminate non-critical parameters.
Knowledge Management will be introduced to keep the information and knowledge gained transparent and available for the full lifecycle of the product. The case study will investigate how a systematic approach to pharmaceutical development and optimisation, respectively, will be faster and will lead to robust processes. Potential internal savings and regulatory flexibility will be discussed with a key European regulator.
The course will also provide an overview on global requirements including new relevant EU regulations and discuss opportunities for an optimal QbD submission.