Practical Approaches to Quality by Design (QbD) for Pharmaceutical Process Research, Development and Manufacturing

1 - 3 November 2016, Boston, United States

Introduction

This course focuses on practical approaches to accelerated QbD implementation, and it makes practical recommendations for realistic implementation of QbD elements. Participants will learn how to prioritize process parameters for screening designs, how to design robust processes using statistical design of experiments (DoE), how to bridge the bench and the commercial design spaces using mixing and scale-up calculations, how to quantify process risk, how to select suitable process analytical technology tools (PAT) and more. For the benefit of process scientists, engineers, formulators, analytical chemists and manufacturing personnel, this course includes highly interactive, hands-on workshops, based on several case studies. Effective technology transfer to pilot and manufacturing plants is also discussed, including process validation in the QbD paradigm.