From GAMP5 revision and CSA-based validation methods to responses for cloud, DI, and AI.
This seminar systematically organizes the basic concepts of CSV and standard lifecycle management, explaining the risk-based approach as indicated by GAMP5 2nd Edition and CSA using practical examples. It will cover practical steps for CSV activities using examples of cloud implementation, addressing CSV compliance for data integrity and AI, as well as a live Q&A session. *For more details, please check the related links or the seminar details in the catalog.*
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<Event Information> Format: Live Streaming (Zoom) / Archive Streaming Date and Time: 【LIVE Streaming】November 11, 2026 (Wednesday) 13:00 - 16:30 【Archive Streaming】November 13 - November 27 (Available for viewing multiple times) Participation Fee: 49,500 yen per person (tax included) Instructor: Yosuke Arai
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<Seminar Program (Tentative)> Chapter 1: Basic Concepts and Overview of CSV Compliance Chapter 2: Trends in the Latest Guidelines (GAMP5 2nd Edition & CSA) Chapter 3: Practical Steps for CSV Activities Using Real Examples of Cloud Implementation Chapter 4: CSV Compliance in Recent Key Themes Chapter 5: [Live Only] Q&A Session
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We support Japan's "monozukuri" (manufacturing) with reliable services ranging from patent research and other intellectual property business solutions to technical translation services and intellectual property/engineer education. We offer high-quality services backed by over 40 years of experience at reasonable prices.
