Date:
November 7, 2024 9:00 a.m. – 4:30 p.m.
Location:
Online
Click hereto 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 foundation 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 Work
- Understanding the Reasons Why Agile Work Is Necessary
- Decision-Making: When to Use Agile, When to Use the Traditional Approach: 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
- Key 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, Functional, Configuration, Design, and Module Specifications
- Risk Management
- Testing / Verification—Phases, Handling Deviations
- System Operations - Change and Configuration Management, Periodic Reviews
Fundamentals 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 Based on a Jira Implementation
Learning Objectives:
After this workout
- You are familiar with the basic aspects of validation.
- Do you know what agility really means?
- You'll get a brief introduction to Scrum.
- Do you know of an approach that combines GxP requirements with agile working?
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 exploring a wide range of agile topics for several years. In particular, the reasons for the success and failure of agile transitions are a key area of research and interest for Mathias.
He has successfully led several agile workshops and is a speaker at conferences on agile topics.