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: Fred Ohsiek, Cleaning Validation ExpertGrouping equipment for cleaning validation is a common practice for reducing execution, resources, and production downtime. Though regulatory [1] [2] and industry guidelines [3] support the practice and provide guidance, there is a clear requirement for scientific justification.Common industry practice is to either avoid grouping because of perceived risk […]
Created by: Fred Ohsiek, Cleaning Validation ExpertThis article not only applies to high potent (HP) active pharmaceutical ingredient (API) manufacturing, but it also includes pharmaceutical manufacturing products with HP APIs; therefore, the term “HPAPI manufacturing” and “HPAPI product” applies to both types of production.It is important that the requirements for the finished manufacturing companies are […]
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