MODULE 3

Impact and risk assessment

Aims

The aim of this module is to provide the candidate with an understanding of the advantages to use risk assessment properly and where and in which stages this technique can be used. Different techniques to perform the risk assessment will be included.

Learning outcomes

On completion of this module the candidate will be able to:

• Understand the purpose of impact and risk assessment.
• Understand different risk assessment techniques.
• Understand the importance and the possible improvements/savings in projects.
• Perform impact assessment of systems and criticality assessment of components.
• How and where to document the assessments made.

Tutor Information

JAN E C GUSTAFSSON

Jan E. C. Gustafsson, PhD, is senior principal scientist, Quality Support, Novo Nordisk A/S, Denmark. The subject for his doctor´s dissertation was to find and analyse human proteins from different body fluids. He has over 30 years experience in management positions and has worked in 3 countries. He has experience of working within executive management groups as vice president of 4 companies during 15 years. Throughout the years, quality, development, production, biopharma and validation have been important parts of his work.

In ISPE he has been active in the European team, extended team and author of one chapter in the ISPE Baseline Guide on Commissioning and Qualification. He is one of the dual leadership of ISPE Baseline Guide “Biopharmaceuticals” and is member of the core team, and chairman of the European team. He is also member of ISPE Technical Documents Steering Committee, and has been active for a long time to create the MSc-course “Industrial Validation Science” at Dublin Institute of Technology, Ireland. During the years, he has made numerous presentations on different subjects internationally.