Zuwei has more than 25 years’ experience in Global Life Sciences Industry. Prior to Lisure, Zuwei was an industry consultant for 3 years in Zenith/Cognizant specializing in MES and PAS. Zuwei was a global Life Sciences industry consultant for Emerson Automation Solution for 6 years prior to that, specializing in MES, Process Analytics, and Advanced Process Control (APC). He had 16 years with GE Healthcare Life Sciences (Cytiva), having taken different roles from application support, to custom process engineering, to product marketing. Zuwei has been involved in various engineering projects in global Life Sciences Industry and is well versed with the best practices in cGMP regulated environment. He has a Ph.D. in Chemical Engineering from Ohio State University.
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they face challenges that have grown with the expansion of processing scale in the industry.
Continued process verification (CPV) as defined in the US FDA process validation guidelineUS Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” 2011. https://www.fda.gov/media/71021/download helps bring quality management and compliance in the pharmaceutical industry to the next level, but it has been challenging to...