You will be exposed to the authors of EFPIA's mock document that mimics a hypothetical application. It reflects what would be done for a (bio-)chemical, pharmaceutical and analytical development conducted under a QbD approach for a biotech API and an injectable product. The document illustrates step by step what experiments were conducted to identify and define critical quality attributes and deduce critical process parameters. It leads you through the unit operations and the definition of their design space as well as the control strategy applied. This workshop exposes you to:
•The latest news from the Yokohama ICH Meeting on Q8, Q9, Q10 and Q11
•A sneak peak on EFPIA's Mock documents for QbD applied to developing biotech and injectable products
•Regulatory expectations and experiences with QbD
•QbD and Real-Time-Release Testing
•QbD - application to biotech processes and information transfer
•Case study of an integrated QbD approach for science- and risk-based process development from an API to a drug product
•QbD in formulation and process development for a freeze-dried parenteral, a case study made in cooperation with FDA
•Parametric/real time release testing achieved using rapid microbiology methods as a QbD tool
•QbD/PAT implementation in drug product manufacturing for an already marketed commercial product and the tools applied.
Here, the very basic issues on cost and choice of investments, cost saving, and return on investment are illustrated and you will have a realistic view on the benefits that can be obtained. Meet and discuss these issues with regulators from AFSSAPS, PIC/S, MHRA and EMEA as well as industry champions.

A New Workshop Experience:
To maximise your benefits from attending, the workshop is designed to open for specific questions you might have. Therefore, coffee shop tables will be set up to pre-defined topics but also to topics participants are indicating during the event. All lecturers have committed themselves to be present and to discuss topics brought up. You are encouraged to join tables following your specific interests. This will enable the beginner as well as advanced practitioner in QbD to get the maximum return out of this event. Notes from all coffee shop tables will be taken and distributed to the participants after the event.