[Seminar] Specific Understanding of Change Application and Minor Changes, and Response to Discrepancies Found
A basic understanding of minor changes and their issues, along with explanations of how to identify discrepancies and respond quickly, illustrated with case studies!
Our company will hold a seminar titled "Understanding of Minor Changes and Change Applications, and Response to Discrepancies - To Prevent Shortages and Product Recalls Due to Discrepancies with Manufacturing and Marketing Approval Documents." The seminar will cover notifications and Q&A regarding minor changes/change applications, the differences between minor changes and change applications, points of caution and countermeasures in change management based on actual cases, the relationship between change management and production response, key points to prevent unnecessary incident reports/product recalls, recent issues raised, and inspections to identify discrepancies, all explained practically based on abundant examples. To prevent issues, it is essential to first understand, then confirm the PDCA cycle, and put it into practice. 【Seminar Overview (Partial)】 ■ Date: March 5, 2026 (Thursday) 10:00 AM - 4:30 PM ■ Venue: Online participation only (Zoom system) ■ Participation Fee (including tax): 49,500 yen ■ Course Materials: PDF materials (included in the participation fee) *Please apply early as registration will close once the capacity is reached.
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basic information
【Acquired Knowledge】 ■ Understand notifications and Q&A regarding minor changes and variation applications ■ Know the differences between minor changes and variation applications ■ Learn about the points of caution and countermeasures in change management from several actual cases ■ Understand the relationship between change management and production response ■ Apply this knowledge in practice to prevent unnecessary submission of incident reports and product recalls ■ Be aware of recent findings in GMP compliance inspections by PMDA ■ Understand inspections to identify discrepancies, etc. *Please apply as soon as possible, as the application will close once the capacity is reached.
Price information
■Tuition fee (including tax): 49,500 yen per person
Price range
P2
Delivery Time
Applications/Examples of results
Please apply as soon as possible, as the application will close once the capacity is reached.
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Company information
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.
