Speaker Francisco Vicenty (Former FDA), Director of Continuous Improvement, Getinge Khaled Moussally, Executive Vice President, Corporate Development & Operations, Compliance Group
Kim Huynh-Ba, Managing Director, Pharmalytik, LLC Introduction Efficiency in laboratory operations is essential for maintaining accuracy, reducing turnaround time, and ensuring compliance with regulatory requirements. As technology advances, laboratories can leverage automation, artificial intelligence (AI) and machine learning (ML), cloud-based Laboratory Information Management Systems (LIMS), and real-time analytics to streamline workflows, optimize processes, and improve […]
Created by: Jennifer Spiegler, Staff Validation Engineer at Janssen Biologics Leiden, the NetherlandsIn traditional monoclonal antibody (mAb) manufacturing, the first purification process step of crude harvest (obtained from cell culture) is Protein-A Chromatography. This expensive column resin is often under-utilized for clinical or orphandrug products since the chromatography columns are dedicated per product. In this […]
A chart describing various maturity levels in data integrity from ISPE GAMP guidance.ISPE-GAMP-Data-Integrity-Maturity-ModelDownload
