Out-of-Specification Investigations

Stream: Quality Control, Analytics & Product Release

How to manage out-of-specification (OOS) results through structured Phase 1 and Phase 2 investigations, root cause analysis, CAPA development, and practical sterility and process-control case studies.

Learning Objectives: 

• Distinguish out-of-specification, out-of-trend and suspect results, and respond appropriately to each
  
• Structure a Phase 2 investigation that will withstand regulatory scrutiny
  
• Apply root cause analysis tools and translate findings into effective CAPA
  
• Interpret sterility results and process control charts in an investigation context

Modules: 

1. Introduction to OOS & Suspect Results in Biomanufacturing
   
2. Phase 2 Investigation, Root Cause Analysis & CAPA
   
3. Sterility, Process Charts and Case Studies

EST. COMPLETION 60 MIN - E-Learning format