[Seminar] Common "Observations and Deficiencies" in GMP Inspections by Regulatory Authorities
There are common signs among the deficiencies pointed out as "serious issues" by regulatory authorities in various countries such as the FDA, EMA, and PMDA!
We will hold a seminar titled "Points for Preemptive Action to Avoid Common 'Observations/Deficiencies' and Major Observations in Regulatory Authority GMP Inspections" to prevent serious issues from being pointed out during inspections. The seminar will break down the latest trends and real examples, as well as quality systems, manufacturing records, DI, electronic data, and other points where companies are likely to fall into traps, providing specific preemptive measures to prevent serious observations. Participants will systematically acquire know-how that can be put into practice starting tomorrow, including preparations for unannounced inspections, strengthening internal audits, and building a quality culture. 【Seminar Overview (Partial)】 ■ Date: February 26, 2026 (Thursday) 10:00 AM - 4:00 PM ■ Venue: Online only (Zoom system) ■ Participation Fee (including tax): 49,500 yen ■ Course Materials: PDF materials (included in the participation fee) *Please apply early as the registration will close once the capacity is reached.
basic information
【Acquired Knowledge】 ■ Trends and examples of findings from regulatory authority inspections ■ Data integrity and quality culture ■ Unannounced inspections ■ Internal audits, 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
OTHER
Applications/Examples of results
Please apply as soon as possible, as the registration 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.