SCRUM Development in Regulated Environments

Agile methods in software development, such as Scrum, more and more dominate the classical waterfall and V-model approaches, to which Computerized System Validation has been oriented. It is commonly argued that using the Scrum method inhibits achieving the requirements for validation in regulated industries.

Nothing is further from the truth. Scrum strives to achieve the same quality results as the waterfall methods. As such, Scrum can be integrated into the Quality Management System when used in regulated industries.

CTG is offering a one-day workshop on how to work with the Scrum Framework in practice. The workshop will specifically highlight on how to bring Computerized System Validation activities on board of Scrum.

Upcoming

Currently no (other) upcoming dates are planned for this course

Course Objectives

The goal of this course is to learn how validation principles perfectly fit into Scrum, by means of several practical exercises.

Each participant will:

  • Receive an introduction into the world of Scrum, Regulatory Compliance, and Computerized System Validation;
  • Understand the concept and approach to develop a Quality Management System within the Scrum framework that supports Computerized System Validation;
  • Experience Scrum in a regulated environment by hands-on exercises;
  • Leave the workshop with a number of practical guidelines and recommendations on how to bring Computerized System Validation into Scrum.

At the end of the course, participants will be able to conduct their own Scrum in Regulated Environments project.

Typical Audience

While the focus of the workshop is mainly for Product Owners, Scrum Masters, Scrum Developers, and Validation Subject Matter Experts who want to leverage validation into the Scrum framework, any member of your organisation who is interested in how to use Scrum in a regulated environment would find this workshop useful.

Typical attendees to this workshop are Business Executives, Project Managers, Quality Assurance Managers, Business Analysts, and any other role that support product development and your business.

Course Prerequisites

No specific prerequisites are required. However, we strongly suggest that participants should have at least 6 months experience in computerized system validation or scrum development and a basic knowledge of English.

Course Delivery

Throughout the course, a highly experienced Scrum and computerized system validation expert provides lectures and gives exercises based on real world projects.

Courses can be given in English or in Dutch. Course material is in English.

Course Venue

The course duration is 1 day.
This course can be given at the client’s site or at CTG.

Course Administration

Pricing

€ 750 per person for one day
€ 695 on second subscription for the same company
€ 600 on third (or more) subscription for the same company

All prices are VAT excluded; course material, lunch and beverages included.

Cancellation

  • By Participant: If a subscribed course participant is replaced by another participant or if the public course is postponed to a later date, no cancellation costs apply. A participant or a group that fails to attend, or that cancels a course without at least 15 working days written notice prior to the course start, is liable for the full subscription cost.
  • By CTG: CTG reserves the right to cancel a course at any time.

Course Logistics

All classroom courses begin promptly at 9 am and are scheduled until 5 pm. Registration as of 8.30 am. All courses are organised at the CTG premises in Diegem (Belgium).
All courses can be given at the client site and are available for groups as well. Please contact us if you wish further information.
Maximum Participants: 10

Course Outlines


  • Introduction to Scrum and Regulatory Compliance
  • Hands-On - Sprint Zero
    Where your software development & validation begins
    Compliance Analysis, Release Planning, Definition of Done Documentation
  • Hands-On - Sprint Planning
    Product Backlog, User Stories, Sprint Backlog, Task Breakdown
  • Hands-On - Sprint Execution
    Development, Testing, Documentation, Validation
  • Hands-On - Use of Electronic Tools
    Importance of Continuous Integration
  • Hands-On - Sprint Review & Sprint Retrospective
    Importance of Demo
  • Hands-On - Daily Stand-up
    Wrap-Up

Meet our trainers

CTG's trainers are experts in their domain and bring the course content based on their experience. Meet some of our trainers below.
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Contact

Europe

CTG Belgium NV

Woluwelaan 140A
1831 DIEGEM
Belgium
phone: +32 2 720 51 70
fax: +32 2 725 09 20

North-America

Buffalo, New York

800 Delaware Ave

Buffalo, NY 14209-2094

phone: +1 716 882 8000

fax: +1 716 887 7464