We help you with the technical writting to support the CMC part with enhanced approaches (QbD) and advanced Control Strategies.
Quality by Design in chemical-pharmaceutical development
QTPP, CQAs, CPPs. Formulation and process design protocols and reports.
Risk analysis during development, scale-up and process validation.
Consulting, training and advice on the practical application of Design of Experiments: screening, optimization and robustness.
Advice and project management on the selection and deployment of Process Analytical Technologies PAT .
How to start? Try our Quality by Design hands-on course.
This course has been the starting point for a Quality by Design deployment in many companies since 2005. More than 300 professionals have acquired new skills with it. We have been updating and refining the contents during the last years to fulfill current requirements and to show common practices in pharmaceutical companies.
The course is customisable to adapt examples to different products: solids, sterile/aseptic, biologics, drug substances, generics and innovators.
You will be skilled in the key QbD tools
QbD CONCEPTS & METHODOLOGY
ICH Q8&Q11. Regulatory scenario FDA vs EMA. What are required elements of QbD that should be present in your submission file. Step by step methodology. Case Study: customer decides what kind of product to show.
Review of the Risk Analysis toolbox. What fits better to each situation or development stage.
Interactive workshop on desired pharmaceutical form or drug susbstance (info sharing under CDA).
Design of Experiments (DoE)
DoE fundamentals. Experimental strategy. Statistical assessment and modelling. DoE workshop session with practical examples for screening and optimisation. Use of DoE software: JMP and Minitab.
Ask for a quote
We just need to know the number of participants (in-company) , the location and the intensity (from 12 to 24 h).