GCP Audit Seminar to Enhance "Efficiency" in the Era of Revised ICH-GCP
IR Technical Education Research Institute will hold a GCP Audit Seminar on June 26, 2026, to enhance "efficiency" in the era of revised ICH-GCP. The seminar aims to teach quality management from an ISO9001 perspective, practical GCP audit procedures, and key points for vendor audits.
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IR Technical Education Research Institute will hold a public seminar where participants can learn about the approach to GCP audits that avoids over-reliance on checklists, the positioning of internal audits, and the key points of vendor (supplier) audits, all within a continuous flow. This will be organized from the perspective of ISO9001, based on the quality management concepts required by the revised ICH-GCP.
Since the issuance of the revised ICH-GCP (ICH-E6(R2)), its implementation has been progressing sequentially in various countries and regions. In Japan, after the start of operations through notifications, the understanding and initiatives on site have not been uniform.
The revised ICH-GCP emphasizes "efficiency," and it requires the operation of a Quality Management System (QMS) that ensures quality in drug development and clinical trials while leading to process improvements.
Seminar Details
Seminar Name: Global Standard GCP Audit
Series Name: 《 ICH-GCP Required Drug Development and Clinical QMS Series 》
Format: Venue (Nihon IR Co., Ltd. Headquarters Seminar Room) or Zoom (Online Lecture)
Date and Time: June 26, 2026 (Friday) 13:30-16:30
Tuition Fee: 19,800 yen (tax included) (Group discount or GCP seminar set application discount available)
Instructor: Tomohiro Niimi, Lecturer (Representative Employee, Antele Group LLC)
Seminar Overview
In this seminar, after outlining quality management based on ISO9001, participants will learn a new approach to GCP audits, which is the concept of internal audits, as a way to prevent QMS from becoming a mere formality. Furthermore, key points of vendor audits will also be covered, with explanations focused on practical application.
Seminar Program
Terminology (Quality / Management / System)
Quality Management by ISO9001 (7 principles, 4 performances, etc.)
ISO9001 and ICH-GCP (Organization of Quality Management and Risk Management, Message of Revised ICH-GCP, etc.)
About Drug Development QMS (fit for purpose, issues of QMS formalization, etc.)
About Internal Audit (misconceptions of independence, goals of audit, positioning of checklists, audit reporting, etc.)
About Vendor Audit (pitfalls, 5 points)
Target Audience
Those involved in drug/medical device development and GCP-related operations
Especially audit personnel and quality management personnel
*For more details on this seminar, please visit here:
https://nihon-ir.jp/seminar/global_gcp-audit/
IR Technical Education Research Institute will continue to provide practical knowledge and know-how useful in the field through technical engineer education services (seminars, e-learning, training, publishing) for the manufacturing industry.
Nihon IR Co., Ltd.
In addition to patent and intellectual property solutions with over 50 years of experience, we offer a wide range of highly specialized practical services centered on technology, including technical information research and analysis, technical engineer education for the manufacturing industry, and technical content creation.
◆Company HP: https://nihon-ir.jp/
◆IR Technical Education Research Institute: https://engineer-education.com/
〒101-0033 15-1 Kanda-Iwamotocho, Chiyoda-ku, Tokyo, CYK Kanda-Iwamotocho 3F
TEL: 03-6206-4966
Since the issuance of the revised ICH-GCP (ICH-E6(R2)), its implementation has been progressing sequentially in various countries and regions. In Japan, after the start of operations through notifications, the understanding and initiatives on site have not been uniform.
The revised ICH-GCP emphasizes "efficiency," and it requires the operation of a Quality Management System (QMS) that ensures quality in drug development and clinical trials while leading to process improvements.
Seminar Details
Seminar Name: Global Standard GCP Audit
Series Name: 《 ICH-GCP Required Drug Development and Clinical QMS Series 》
Format: Venue (Nihon IR Co., Ltd. Headquarters Seminar Room) or Zoom (Online Lecture)
Date and Time: June 26, 2026 (Friday) 13:30-16:30
Tuition Fee: 19,800 yen (tax included) (Group discount or GCP seminar set application discount available)
Instructor: Tomohiro Niimi, Lecturer (Representative Employee, Antele Group LLC)
Seminar Overview
In this seminar, after outlining quality management based on ISO9001, participants will learn a new approach to GCP audits, which is the concept of internal audits, as a way to prevent QMS from becoming a mere formality. Furthermore, key points of vendor audits will also be covered, with explanations focused on practical application.
Seminar Program
Terminology (Quality / Management / System)
Quality Management by ISO9001 (7 principles, 4 performances, etc.)
ISO9001 and ICH-GCP (Organization of Quality Management and Risk Management, Message of Revised ICH-GCP, etc.)
About Drug Development QMS (fit for purpose, issues of QMS formalization, etc.)
About Internal Audit (misconceptions of independence, goals of audit, positioning of checklists, audit reporting, etc.)
About Vendor Audit (pitfalls, 5 points)
Target Audience
Those involved in drug/medical device development and GCP-related operations
Especially audit personnel and quality management personnel
*For more details on this seminar, please visit here:
https://nihon-ir.jp/seminar/global_gcp-audit/
IR Technical Education Research Institute will continue to provide practical knowledge and know-how useful in the field through technical engineer education services (seminars, e-learning, training, publishing) for the manufacturing industry.
Nihon IR Co., Ltd.
In addition to patent and intellectual property solutions with over 50 years of experience, we offer a wide range of highly specialized practical services centered on technology, including technical information research and analysis, technical engineer education for the manufacturing industry, and technical content creation.
◆Company HP: https://nihon-ir.jp/
◆IR Technical Education Research Institute: https://engineer-education.com/
〒101-0033 15-1 Kanda-Iwamotocho, Chiyoda-ku, Tokyo, CYK Kanda-Iwamotocho 3F
TEL: 03-6206-4966