About Pre conference course H - Biosafety in a GMP World

GMP requirements are rooted in strict, non-negotiable legislation while biosafety relies on the nuanced art of risk assessment. These two domains share significant synergies but also harbor conflicts. Misalignment between GMP and biosafety standards can lead to facilities that fail to fully comply with biosafety, compromising containment design, improper airflow management, and increasing risk of carry-over of contamination and release. 

The lack of a unified approach to harmonize GMP and biosafety guidelines presents a significant challenge. This course will explore how both can be implemented seamlessly, ensuring optimal facility design, compliance, and operational safety. Participants discover innovative strategies for bridging this gap and fostering harmony between GMP and Biosafety in their own facility.  

Learning Objectives:

• Analyze and point out the differences and synergies between GMP and biosafety  
• Design and implement solutions that are compliant with both GMP and biosafety. 
• Evaluate and modify risk assessments to incorporate biosafety concerns effectively within GMP settings.

Main topics:

• GMP in a nutshell 
  • What is GMP 
  • GMP regulations and requirements 
  • Why is GMP important 
• Biosafety in GMP environments
  • Risk Assessments considering both GMP and Biosafety  
  • GMP and BRM synergies and conflicts 
  • Large-scale-facility design, engineering and equipment controls 
  • Waste Management of a large-scale facility 
  • Human factors and Biosafety training in a GMP setting  
  • Emergency responsein a manufacturing facility  
  • Working with stakeholders