About EBSA19 - Course A - Design and implementation of the biorisk management system

Course description

Recent breaches of biosafety and biosecurity have emphasised that management failure is normally the root cause of accidents and incidents with biological agents and toxins. Implementation of a systematic biorisk management system, e.g. adopting the CWA 15793 can help organisations manage these risks. The CWA 15793:2011 "Laboratory Biorisk Management” is the first internationally recognized management document to specifically address hazards associated with laboratories where biological materials are handled at all containment levels. With respect to individual state legislation, CWA 15793 is a compendium of all biosafety issues irrespective of actual laws or administrative provisions. It defines key requirements encompassing all relevant laws and does not focus on the application of individual pieces of legislation and by thus does not contradict any existing guidelines.

The 2-days-course will start with the introduction of the principles of a biorisk management and how the multiple components of a biorisk programme can be integrated into the management system(s) in place or to be developed in an institution. Participants will be asked to give a short presentation of their institution at the beginning of the course. The main emphasis of the two days will be the opportunity for the participants to work on a scheme for implementation of a biorisk management for their respective home institutes.

The course participants will be able to:

• Identify the fundamentals of a biorisk management system
• Understand the intent of the CWA 15793:2011 with emphasis on:
  • Plan-Do-Check-Act cycle
  • Policies
  • Documentation control
  • Hazard identification & risk assessment (incl. risk control)
  • Operational control
  • Emergency response and accident and incident investigation
  • Training, awareness and competence
• Initiate or improve the implementation of the CWA 15793:2011 for their institution

To optimize the individual benefit, the course instructors will contact the participants in advance to recommend which information of their home institutions the participants should bring along (if available).

CWA 16335:2011 Biosafety professional competence references

The topic refers to competence 7.2.17 and training specifications C.2.1.2.15 of CWA 16335:2011 Biosafety professional competence.

Instructors:
Juergen Mertsching
Urs Pauli