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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 behavior-based safety and human factors approach is a proactive and comprehensive strategy aimed at identifying and addressing at-risk behaviors in laboratory settings. This approach emphasizes the importance of individual behaviors in creating a safe work environment and preventing accidents and injuries.

Additional to technical knowledge, a successful career in biosafety or biosecurity requires a number of transferable professional skills. This course will give participants grounding and insight into key skills used by professionals in many areas, and examine how those impact upon a career in biosafety / biosecurity both generally and specifically. 

After introducing the basic definitions, the course will cover two major topics: the strategy to identify cell culturesand the risks related to cell cultures and appropriate mitigation measures. Each part will involve interaction with participants, including a final short quizby groups of 3-4.

Imagine you see yourself in a situation in which you have to decide on the biological risk classification of a new biologic and decide on the safety measures required to protect the people working in the lab and the environment and you have never come across any similar biologic, if it is biologic at all. This course is as much about risk assessment and risk management as it is about the process to find an answer and come to conclusions as well as dealing with uncertainty.

The planning, design, construction and performance review of high containment facilities, including BSL-3, ABSL-3 and BSL-3Ag, requires a well thought out approach if the outcome is to meet the intentions of the owner or client and the users. 

Aim: To be competent in undertaking biological risk assessment in an in vitro containment facility. 

This full-day course provides a comprehensive introduction to laboratory biosecurity principles, focusing on the practical application of risk assessment strategies. Participants will explore the WHO Laboratory Biosecurity Guidance, examining the connections and distinctions between biosecurity and biosafety.