wega Informatik AG - building the bridge between Business and IT
Agile validation in GxP projects
Date:
Tuesday, June 04, 2019
Location:
Hall Literaturhaus, Basel, Barfüssergasse 3, 4051 Basel, Switzerland
Abstract:
| The IT landscape in organizations is changing extremely fast and it is necessary to be able to react quickly to these changes. Agile approaches are now widely used in many areas where software development is used to cope with these frequent changes and to ensure that business requirements are clearly understood. However, Agile approaches tend not to be used in GxP-regulated environments due to incorrect assumptions: Agile is NOT about chaos, freestyle, absence of documentation, as you often hear. In reality, the successful application of agile methodology always requires an even more precise process definition for team collaboration than you would in a classic V-model approach. In this session, you will learn how the benefits of agile methods can be applied within GxP validation projects. |
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We will address relevant topics such as:
- Introduction to the agile vs. GxP/GAMP challenge
- Possible agile approaches in the GxP project
- Lessons learned from specific projects
- Key requirements for successful agile validation
Our Speakers:
Evelyne Daniel
Evelyne has been working in regulated environments for more than 20 years and has been involved in IT projects as a project manager or validation manager since 2005. Evelyne has successfully implemented and validated several systems, mainly in the area of QA/QC/manufacturing. For many years, Evelyne has been involved in the optimization of validation strategies and documentation standards. With the increasing adoption of agile development frameworks, new validation concepts, adequate tools and skills are required. It is Evelyne's ambition to actively contribute to the establishment of agile validation methods.
Mathias Fuchs
Mathias is a Scrum Master, Agile Coach, IT consultant and since 2011 co-host of the non-profit Swiss ICT event series: "Agile Breakfast Basel". Mathias has been dealing with agile topics of all kinds for several years. In particular, the reasons for the success and failure of agile transitions are an important area of research and interest for Mathias.
Mathias successfully led several agile workshops and is speaker at conferences covering agile topics.
Schedule:
08:30 - 09:00:
Come together (registration / coffee & breakfast)
09:00 - 09:05:
Introduction (Mathias Fuchs, wega Informatik)
09:05 - 09:50:
Presentation (Evelyne & Mathias)
09:50 - ~10:30:
Discussion / Networking
Location:
Hall Literaturhaus, Basel, Barfüssergasse 3, 4051 Basel, Switzerland
