FDA Strategic Quality Planning: A Risk-Based Approach for Biopharma Manufacturing Excellence
Client Business Situation See the video of the conference presentation about this case study HERE. Like many regulated life science manufacturers, to proactively reduce risk and focus on continual quality improvement, Bayer Pharmaceuticals’ primary biomanufacturing site in Berkeley, California, engaged in extensive quality and compliance self-analysis during 2015 and 2016. The outcome of this work consisted of […]
