(48a) Quality by Design (QbD) Opportunities, Challenges and Future Direction


QbD is a systematic approach to pharmaceutical development, manufacturing and product lifecycle management. QbD provides new opportunities to utilize state of the art science, quality risk management and modern engineering tools. This presentation will discuss current regulatory guidelines and implementation progress.  In addition, Dr. Nasr will outline some of the challenges and provide suggestions to move forward.   The regulatory role need to be better defined to encourage innovation, facilitate drug development and provide high assurance of quality.