[Seminar] Data Integrity and CSV from Basics to Practice
Thoroughly analyze over 2,900 FDA inspection findings and systematically acquire data integrity (DI) and CSV compliance from the basics to practical levels!
We will hold a WEB seminar on DI and CSV practices titled "Data Integrity and CSV from Basics to Practice in Labs and Manufacturing Based on 2,900 FDA Inspection Cases – Summary Translation of DI Guidance for PIC/S Inspectors" to enhance our inspection response capabilities. The seminar will practically explain the differences between paper and electronic data, audit trail reviews, and how to handle cloud and spreadsheet issues, addressing challenges faced on-site. Utilizing guidance translations from various countries and over 320 materials, participants will develop immediate skills for audit and inspection responses. This special seminar allows for a thorough understanding of practical on-site operations that cannot be grasped through guidance alone. [Seminar Overview (Partial)] ■ Date: November 18, 2025 (Tuesday) 10:00 AM – 4:30 PM ■ Venue: Online only (Zoom system) ■ Participation Fee (including tax): 49,500 yen per person ■ Course Materials: Bound textbook (included in the participation fee) *Please apply early as registration will close once the capacity is reached.
basic information
【Acquired Knowledge】 ■ Data Integrity Inspection Points ■ Practical Response to Data Integrity and Audit Methods ■ Basics of ERES and CSV ■ Spreadsheet CSV/DI Compliance ■ Considerations for Cloud Services, etc. *Registration will close once the capacity is reached, so please apply early.
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 application will close 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.