[Seminar] Rational Validation of Spreadsheets

Explain the operation and management of the spreadsheet by incorporating over 2,900 raw inspection observation cases obtained through a disclosure request to the FDA under the U.S. Freedom of Information Act.

We will hold a seminar titled "Moving Away from Tokenistic CSV: Specific Points for Rational Validation of Spreadsheets and Data Integrity Management and Operations - How much should we write for URS, FS, and DS? What are the dangers of spreadsheets without audit trails? - Quickly usable CSV regulations and template documents." This is an implementation-oriented course that utilizes readily available regulations and document templates to transition to "audit-compliant spreadsheet operations." Based on the key points of GMP, CSV, and ERES, we will systematically explain the scope of URS/FS/DS documentation, the rational level of validation, trends in FDA inspections, and practical points for templating and standard operations. [Seminar Overview (Partial)] ■ Date: February 6, 2026 (Thursday) 10:00 AM - 4:30 PM ■ Venue: Online only (Zoom system) ■ Participation Fee (including tax): 49,500 yen ■ Course Materials: Bound text (included in the participation fee) *Please apply early as the registration will close once the capacity is reached.

Technical Seminar