WEGA WORKSHOP #PLA2019


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 "Agilized 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.

 

Presenter

EDaniel Paperless Lab Academy

Name: Ms. Evelyne Daniel

Title: Senior CSV consultant

Email:info@wega-it.com 

www.wega-it.com  

 

WEGA Informatics Paperless Lab Academy

Wega Informatik AG, 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.

Focused on the R&D / QC & CSV aspects, some of Wega's principal topics are:

Strategic Consulting & Business Analysis

LIMS, ELN, LES and paperless Lab

Compound Management& BioBanking

Research Data & Knowledge Management

Project management and project lead

Smart Lab / Lab of the Future

Industry 4.0 Concepts

Active Contribution to SiLA and AnIML

Project Quality Management (CSV)

GxP Validation Strategies & Documentation

Functional Risk Assessment

Rollout Support

Vendor and in-house audits