Architects Of Quality
Summary: Long used in automotive and electronics manufacturing, quality by design (QbD) is strongly endorsed by the FDA and other regulators. After all, why increase risk and spend time and money ‘firefighting’ preventable problems? Kay Schmidt, vice president of R&D at Catalent Pharma Solutions, an engineer by training and now a QbD practitioner, discusses the important questions that you never dared to asked. Learn about the challenges and successes of the QbD process, and how to apply QbD for your next project. Just like how Catalent developed ADVASEPT® technology – an advanced aseptic process utilizing blow–fill–seal, based on the principles of QbD and applied to the fill/finish industry.