QbDWorks is a resource website dedicated to Quality by Design for Biotech, Pharmaceutical and Medical Devices.
Hello, I’m Sun Kim, PhD. I’ve been working inside (and outside) the Biotech, Medical Device field for 10 years with the goal of innovating how we develop products (drug, therapy, medical device, equipment, and service etc.) in Healthcare. Many years ago, I embarked on a journey to help the industry to adopt “Quality by Design” (QbD) approach. As a researcher-for-life, I have been learning what works and does not along this journey. I would like to share my experiences and thoughts. This blog exists to help the Development Scientists, QbD consultants and project managers who are the core drivers of the QbD paradigm so you won’t have to make the same common mistakes. If you’d like to receive useful contents and connect with the community, please subscribe to this blog. Enjoy!