High Stakes Change Management: Remediation Post FDA Warning Letter

Created by: Chris Gray, Principal Consultant, CAI Your 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 […]

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Role-based Talent Planning for Operational Readiness

Created by: Harry Benson, Director, Human Performance, CAI This 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 […]

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Cleaning Validation Equipment Grouping

Created by: Fred Ohsiek, Cleaning Validation Expert Grouping 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 […]

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Stage 1: High-Potent Active Pharmaceutical Ingredient (HPAPI) Cleaning Validation (CV)

Created by: Fred Ohsiek, Cleaning Validation Expert This 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 […]

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Improving Risk-Based Decision Making Effectiveness: Insights From Other Industries

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, Dublin The 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 […]

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