#Japan #Tokyo #CSA #CSV #GAMP5

Learn about Computerized System Validation and Recent Trends

In today's technological landscape, effective management and validation of computerized systems has become crucial, especially with the rise of advanced technologies like AI and cloud computing. The need for comprehensive Computerized System Validation (CSV) practices is now more significant than ever.

The IAR Technical Education Institute understands this necessity and has organized a public seminar designed to teach essential CSV concepts from the basics to the latest guidelines, including GAMP5 2nd Edition and Computer Software Assurance (CSA). This online event aims to provide attendees with insights on adapting traditional CSV practices to address contemporary themes such as data integrity, cloud integration, and AI applications.

Seminar Overview

The seminar, titled "Learning the Basics of Computerized System Validation (CSV) and Latest Practice Trends,” will be conducted online. Participants can attend a live session on November 11, 2026, from 1:00 PM to 4:30 PM (JST), or access an archived version later from November 13 to November 27, 2026. The participation fee is set at 49,500 yen (including tax) per person, with discounts available for multiple attendees.

Who Should Attend?

This seminar is ideal for the following individuals:

• - Those newly involved in CSV tasks.
• - Professionals looking to catch up on the latest trends and methodologies related to GAMP5 revisions, CSA, and the integration of cloud and AI into CSV processes.
• - Those facing challenges in developing CSV plans or managing daily operations effectively.

The seminar will be led by Yosuke Arai, the representative of Luna Insight, who bears extensive knowledge in the field. With a systematic approach, he will explain critical concepts and various aspects of CSV.

Seminar Curriculum

1. Fundamental Concepts and Overview of CSV

• - The purpose and foundational principles of CSV.
• - Relevant regulations and guidelines impacting CSV.
• - CSV activities in relation to the system development life cycle.
• - Responsibilities of users and suppliers/vendors in the CSV process.

2. Current Trends in Guidelines (GAMP5 2nd Edition & CSA)

• - Focus points of GAMP5 2nd Edition.
• - Key components of CSA.
• - Considerations on whether CSV is necessary.

3. Practical CSV Activities in Cloud Adoption

• - Risk-based approach to CSV planning.
• - Supplier evaluation and vendor audits.
• - User requirements specification (URS).
• - Verification processes (IQ/OQ/PQ).
• - Management of changes, deviations, and operational phases.

4. CSV Challenges in Key Current Themes

• - Understanding data integrity (DI) in relation to CSV.
• - Best practices for CSV in the realm of AI.

5. Q&A Session (Live Only)

Continuing Commitment to Education

The IAR Technical Education Institute remains dedicated to providing invaluable insights and practical knowledge through its technical training services, which include seminars, e-learning, workshops, and publications aimed at the manufacturing sector. In partnership with Nihon IR Corporation, recognized for its over fifty years of expertise in intellectual property and technical solutions, this seminar serves as an opportunity for professionals to enhance their understanding and execute effective CSV strategies.

We invite all interested individuals to sign up and take part in this enlightening seminar designed to prepare professionals for the evolving landscape of technology and validation methodologies. For more details about the seminar, please visit our official page here.