#Japan #Tokyo #Quality Management #ICH-GCP #GCP Audit

Enhancing Efficiency in GCP Audits

The I.R. Technician Education Institute is pleased to announce a public seminar focused on enhancing efficiency in GCP audits following the Revised ICH-GCP guidelines. The seminar is designed to provide a comprehensive understanding of quality management concepts from the ISO9001 perspective, avoiding an over-reliance on checklists through innovative approaches to GCP audits.

As countries and regions progressively implement the Revised ICH-GCP (ICH-E6 (R2)), understanding and application at the ground level vary widely in Japan. The essence of Revised ICH-GCP emphasizes 'efficiency,' necessitating the operation of Quality Management Systems (QMS) that ensure quality while facilitating process improvements in pharmaceutical development and clinical trials.

Seminar Details

• - Seminar Name: Global Standards in GCP Auditing
• - Series Name: ICH-GCP Pharmaceutical Development and Clinical QMS Series
• - Format: In-person (Japan I.R. Co., Ltd. Head Office Seminar Room) or Zoom (Online Lecture)
• - Date and Time: June 26, 2026 (Friday), from 13:30 to 16:30
• - Participation Fee: 19,800 yen (tax included)

Discounts are available for group registrations and GCP seminar package deals.

• - Instructor: Tomohiro Niimi (Representative Employee, Antlle Group, LLC)

Overview of the Seminar

This seminar will provide an overview of quality management based on ISO9001, highlighting approaches to prevent the formalization of QMS. Participants will learn about a new perspective on GCP audits, emphasizing the concept of internal audits. Key points regarding vendor audits will also be discussed, ensuring practical applicability.

Seminar Program

1. Terminology (Quality / Management / System)
2. ISO9001 Quality Management (Seven Principles, Four Performances, etc.)
3. ISO9001 and ICH-GCP (Organizing Quality Management and Risk Management, Messages of Revised ICH-GCP, etc.)
4. QMS for Pharmaceutical Development (Fit for Purpose, Issues of QMS Formalization, etc.)
5. Internal Audits (Misunderstandings about Independence, Goals of Audits, Checklist Placement, Audit Reports, etc.)
6. Vendor Audits (Pitfalls, Five Key Points)

Target Audience

This seminar is ideal for individuals involved in the development of pharmaceuticals and medical devices, particularly those working in GCP-related roles, including audit personnel and quality management stakeholders.

For more details about this seminar, visit our official page: Global GCP Audit Seminar

The I.R. Technician Education Institute is committed to providing helpful knowledge and expertise to the field through its range of educational services, including seminars, e-learning, training, and publishing.

The Japan I.R. Corporation has over 50 years of experience offering patent and intellectual property solutions, technical information research and analysis, education for technical personnel in manufacturing, and creating specialized technical content.
Company Website: nihon-ir.jp
I.R. Technician Education Institute: engineer-education.com
Contact Information: 101-0033, 15-1 Kanda Iwamoto-cho, Chiyoda-ku, Tokyo, 3rd Floor CYK Kanda Iwamoto-cho
Phone Number: 03-6206-4966