To provide students with an introduction to contamination control strategies in the pharmaceutical and biopharmaceutical industries in line with EU Annex 1 regulations.

 

Module Content

• Contamination Control overview
• Regulatory Requirements for aseptic/sterile processing including EU Annex 1 revision
• Quality risk management application in contamination control strategy
• Contamination sources across the pharmaceutical supply chain and lifecycle
• Contamination control strategy
• Open and closed processing with focus on single use technology
• Cleaning & sterilization
• FDA warning letters review