Date:
November 07, 2024 09:00 - 16:30
Location:
Online
Click here to register.
One-day seminar on:
The IT landscapes in companies are developing rapidly, which makes it necessary to be able to react quickly to these changes. Agile validation approaches have become commonplace in software development to successfully manage frequent changes while ensuring that business requirements are clearly understood.
Nevertheless, agile approaches in GxP-regulated environments tend not to be applied due to wrong assumptions:
Contrary to the opinion of many, agile is NOT about chaos, arbitrariness and lack of documentation: In reality, the successful application of agile methodology always requires a process definition for team collaboration that is as precise as it would be in a classic V-model approach.
The basis of a successful agile project under GxP is to critically examine and understand both areas.
Learn more about the event here.
Contents:
Introduction: Understanding agility and agile working
- Understanding the reasons for the need for agile working
- Decision-making: When agile, when classic: waterfall
- What is the agile mindset and why is it so important
Introduction: Scrum
- Introduction to Scrum as the most prominent example of an agile framework
- Most important elements presented: Workflow, roles and responsibilities, events, artifacts
Validation: Laws and regulations for CSV
Elements of computer validation
- Supplier management
- Validation planning and reporting
- User requirements, function, configuration, design and module specifications
- Risk management
- Testing / verification - phases, dealing with deviations
- System operation - change and configuration management, periodic review
Basics of agile validation
- Principles
- Goals
- Agile V-model
- Prerequisites for successful implementation
Introduction and live demo of a possible implementation
- Processes
- Roles & responsibilities
- Artifacts
- Live demo using a Jira implementation
Learning objectives:
After this training
- know the basic aspects of validation.
- you know what agility really means.
- you will have a first brief insight into Scrum.
- you know a procedure in which GxP requirements and agile working are combined.
Our Speaker:
Mathias Fuchs
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 working on a variety of agile topics 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.
He has successfully led several agile workshops and is a speaker at conferences on agile topics.