Breaking away from a checklist approach, sublimation from GCP audits to internal audits, and clearly explaining the key points of vendor audits.
This seminar provides an overview of quality management based on ISO 9001 to correctly understand the messages of the revised ICH-GCP. It will explain the role of internal audits in pharmaceutical development QMS, moving away from document and record-centric approaches, "pseudo QMS," internal audits that lead to performance improvement, checklists that are not for mere checking, performance evaluation of internal audits, vendor audits, and more. *For details, please check the related links or the seminar details in the catalog.*
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<Event Information> Format: In-person attendance / Live streaming (Zoom) Location: Japan IR Co., Ltd. Headquarters Seminar Room Date and Time: June 26, 2026 (Friday) 13:30 - 16:30 Participation Fee: 19,800 yen (tax included) Instructor: Tomohiro Niimi (Representative Member of Antelle Group LLC)
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<Seminar Program (Tentative)> Chapter 1: Terminology Chapter 2: Quality Management according to ISO 9001 Chapter 3: ISO 9001 and ICH-GCP Chapter 4: About Pharmaceutical Development QMS Chapter 5: About Internal Audits Chapter 6: About Vendor Audits
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We support Japan's "monozukuri" (manufacturing) with reliable services ranging from patent research and other intellectual property business solutions to technical translation services and intellectual property/engineer education. We offer high-quality services backed by over 40 years of experience at reasonable prices.
