Applying QbD Principles - From Development, Registration and Beyond - A Case Study Example

The workshop is meant to give not only an introduction into Quality by Design, but also an integrated picture of its application throughout a product’s lifecycle. The format chosen is that of a case study, artificially synthesized from real life examples to demonstrate how the following elements may interlink: control strategy, criticality, CTD, design space, PAT, Design of Experiments, pharmaceutical development, real time release, regulatory flexibility, risk management and target product profile.

Evening Seminar: Use of Statistical Process Control (SPC) in a Pharmaceutical Environment
As ICH Q10 Guideline for a Pharmaceutical Quality System gains momentum within the industry, this seminar will introduce how SPC can address terms such as variability, capability, process, understanding and continuous improvement. The seminar will involve getting to grips with the basic concepts of statistical process control and will show case studies from the pharmaceutical industry.
Workshop Leader:
Tom Cochrane, Business Process Development Manager, Napp Pharmaceuticals, UK

Who can I expect to meet?
This leading industry forum is aimed at Directors, Heads of Department, Team Leaders and Scientists working in the areas of:
• Research and Development • PAT • Compliance
• Process Development & Optimisation • Manufacturing • Formulation
• Quality Assurance/Quality Control • Operations • Regulatory Affairs
• Engineering • Process Science • Process Analytics