Created by: Kimberly Wallbank & Nicole DamourProduct complaints and reports of adverse events are unwelcome events at any company, especially if a product recall must be considered. However, these must be handled promptly and with all due diligence to prevent authentic drug- related events from negatively impacting the health and well-being of patients. This article […]

Created by: Chris Gray, Principal Consultant, CAIYour company has received an FDA warning letter, now what? As an organization finds itself in uncharted waters due to inspection results, the leader’s job is to chart a course and speed to re-inspection success without everyone jumping ship. Leaders must remember historical averages for change success hovers between […]

Created by: Harry Benson, Director, Human Performance, CAIThis paper intends to provide guidance on talent planning, with specific emphasis on role clarity. Given the flurry of activity being conducted during capital projects and transitions to operations, developing a talent plan may appear to be somewhat administrative or insufficiently urgent. This often leads site leaders to […]

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST […]

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 orphan drug products since the chromatography columns are dedicated per product. In […]