About EBSA14 - Course B. Biosafety audits and inspections - a basic course

Instructors:
Helmut Bachmayer, Biosafety & Biosecurity Consultant, Maria Enzersdorf/A
Gary Burns, AstraZeneca PLC, Macclesfield/UK

Short description:
This workshop is intended to provide a basic course on auditing management systems and monitoring safety performance in connection with activities involving biohazards. In addition to setting out the general framework for the audit process, and contrasting this with safety inspections, a number of scenarios will be presented to illustrate some of the difficulties which may be encountered, along with approaches to circumvent these. Points to consider when planning and conducting an audit will be presented together with useful hints based on the auditing experience of the tutors. Based on a case study, audit preparation and strategy as well as communication will be practiced in group work and role playing.