【Seminar】Basics of GMP
A systematic explanation from the basics of GMP, the role of QC, raw data management, to OOS/OOT responses!
We will hold a WEB seminar titled "Basics of GMP - Especially QC, Raw Data Management, Change Management (Overview), and OOS/OOT." Based on the revised GMP regulations, PIC/S, and FDA cases, we will organize the concepts of data integrity and change management with concrete examples. In the OOS/OOT section, in addition to explaining the guidelines, we will discuss past drug-related incidents from a statistical perspective to clarify the actual judgment and response, elevating the understanding of GMP from "understanding" to a level where one can "make judgments on-site." This program is available for individuals from pharmaceutical companies, contract manufacturing organizations, and chemical companies, regardless of their level of expertise. 【Seminar Overview (Partial)】 ■ Date: April 14, 2026 (Tuesday) 13:00 - 16:30 ■ Venue: Online only (Zoom system) ■ Participation Fee (including tax): 38,500 yen per person ■ Course Materials: Printed textbook (included in the participation fee) *Please apply early as the registration will close once the capacity is reached.
basic information
【Acquired Knowledge】 ■Basic knowledge of GMP ■Role of QC in GMP ■Handling of raw data and ensuring reliability ■Basic knowledge of data integrity ■Basic knowledge of change management ■Concepts and judgments regarding OOS and OOT, as well as responses and procedures ■Statistical approaches *For more details, please download the PDF or feel free to contact us.
Price information
■Tuition fee (including tax): 38,500 yen per person
Price range
P2
Delivery Time
OTHER
Applications/Examples of results
For more details, please download the PDF or feel free to contact us.
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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.