WEGA WORKSHOP #PLA2020


Agile Validation in GMP Projects

Overview

Brief Introduction to the challenge Agile Vs GxP/GAMP
Possible Agile Approach in Validation Project "Agilized Waterfall"
Lessons Learned out of concrete projects

Session learnings

Possible Agile Approach
Avoid pitfalls

Areas covered in this session 

Brief Introduction to the challenge Agile Vs GxP/GAMP
Possible Agile Approach in Validation Project "Agilised Waterfall"
Lessons Learned out of concrete projects
Discussion on pros/cons

 

 

Who should benefit

Any person interested in good practice for IT projects, especially in a GxP environment.

Why should you attend 

IT landscape in companies changes extremely fast and it is necessary to be able to react quickly to these changes.
Agile approaches are nowadays very commonly used in many areas where SW development is used to be able to overcome these frequent changes and to ensure that business needs are clearly understood.
Still, in a GxP regulated environment, Agile approaches tend to not be applied because of wrong assumptions/understanding: Agile is NOT about Chaos, Freestyle, Absence of Documentation, as one can often hear.
In reality, successfully applying agile methodology always requires even more precise process definition for team collaboration as one would do in a classical V-model approach.
In this session, you will learn how the advantages of agile methodologies can be applied within GxP validation projects.

Presenters

EDaniel Paperless Lab Academy

Name: Ms. Evelyne Daniel

Title: Senior CSV consultant

Email:info@wega-it.com

 

EDaniel Paperless Lab Academy

Name: Mr. Mathias Fuchs

Title: Senior CSV consultant

Email:info@wega-it.com

 

Evelyne is working for more than 20 years in regulated environments and is acting since 2005 as Project manager or Validation lead in IT projects. Evelyne successfully implemented and validated several systems, mainly in QA/QC/Manufacturing. For many years, Evelyne is looking into optimization of validation strategies and documentation standards. With the growing 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 methodologies.

Mathias is Scrum Master, Agile Coach, IT Consultant and since 2011 Co-Moderator of the non profit Swiss ICT event series: "Agile Breakfast Basel". Since several years Mathias is engaged in all kinds of agile topics. Especially the reasons for success and failure of agile transitions is a major field of investigation and interest of Mathias.
Mathias sucessfully led several agile workshops and is speaker at conferences covering agile topics

mega Informatik paperless lab academy with 25 years of experience, we are the preferred partner of IT and business departments to support their R&D and QC projects. Our experts offer in-depth expertise in various areas to help your professionals to understand their business and technical needs and provide perfect support to find and establish a state of the art environment.

Through the tight collaboration between our 4 internal groups, Clinical Development IT, Lab & Research IT, CSV & QA and IT Solutions, Wega provides the full lifecycle support to your company.

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