[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.
basic information
【Acquired Knowledge】 ■Basics of Data Integrity ■Points Raised by FDA Inspections ■Validation of Spreadsheets ■Spreadsheet Validation Regulations ■Spreadsheet Validation Document Templates ■Operation of Templates, etc. *Please apply as soon as possible, as the deadline will be closed once the capacity is reached.
Price information
■Tuition fee (including tax): 49,500 yen per person
Price range
P2
Delivery Time
OTHER
Applications/Examples of results
Please apply as soon as possible, as the deadline will be closed once the capacity is reached.
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TH Planning Co., Ltd. is a company that conducts technical seminars, dispatches instructors for training, and provides technical consulting. We aim to contribute to the development of manufacturing and value creation by creating educational opportunities that provide specialized knowledge and know-how in technology and by becoming a hub that connects technologies. Please feel free to contact us when you need our services.