Agile Project Management for Implementation of Regulated (GCP and GMP) Systems

The introduction of Agile Project Management elements can lead to significant benefits, especially in the area of GCP systems, but can also increase risks. Incorrect implementation of the methodology, false interpretations of the Agile Manifesto, changing terminology and overly ambitious expectations by management are often challenges for Quality functions. After Software development has embraced und successfully implemented agile methods as Scrum or eXtreme Programming, similar concepts are now used also more and more in project management activities. The major goal of these agile approaches is to deliver functionality faster to the end user in shorter release cycles This can lead to significant benefits, especially in the area of GCP systems, but can also increase risks. Incorrect implementation of the methodology, false interpretations of the Agile Manifesto, changing terminology and overly ambitious expectations by management are often challenges for Quality functions. This presentation will provide: - Overview of relevant terminology - (mis)-interpretations of the Agile Manifesto - real-live examples of challenges for Quality staff - some ideas for facing the challenge.