Wega Informatik Workshop & Live Session
Agile validation in GMP Projects
Onboarding a QA into the validation concept - Interactive Q&A session
Presenter: Evelyne Daniel, Senior CSV consultant at wega Informatik
Evelyne is working for more than 20 years in regulated environments and is acting since 2005 as Project Manager and Validation Lead in IT projects.
Evelyne successfully implemented and validated many systems, mainly in QA/QC/Manufacturing. For many years, Evelyne is looking into optimisation 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.
Presenter: Mathias Fuchs, Senior CSV consultant at wega Informatik
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 successfully led several agile workshops and is speaker at conferences covering agile topics.
In this workshop we provide a follow up to our previous session that introduced and challenged the agilization of validated GxP projects. Now, some months later, we will show you how we execute a fully agile GxP Project by simulating a LIMS Project.
Onboarding a QA into the validation concept
The first 30 minutes session is a recording of an online meeting between the Validation Expert, the Vendor SME and the QA of the LIMS project. The QA is new and needs to take over the responsibility from his predecessor who left the company. He knows agile framework from the theory and has only supported classical V-model validation projects.
See how the Validation Expert and the Vendor SME explain him the agile project setup and the validation concept in order to get the commitment of the new QA for the project.
Interactive Q&A Session
The second part - also 30 minutes - is the subsequent Q&A session as the new QA has tons of questions and is challenging the new agile approach. This session will be interactive, allowing the audience to also ask questions, express their doubts and share experiences.
Areas covered in the session
- Brief Introduction to the challenge Agile in GxP/GAMP environments
- Potenial Reference Implementation of an agile GxP Development Approach using critical thinking about validation goals
- Combine the agile pillars of transparency, inspection and adaptation with regulatory requirements and documented evidence
- 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.
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. www.wega-it.com