About EBSA10 - Course B. Biosafety audits and inspections - A basic course

Instructors:
Peter Guldbrandsen, Head Corporate HSE Audit, Novartis International AG, Basel, Switzerland
Helmut Bachmayer, Biosafety & Biosecurity Consultant, Vienna, Austria

Short description:
This seminar 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 practised in group work and role playing.