Explanation of key points from preparation to on-site investigation in internal audits, self-inspections, and supplier audits.
This seminar is aimed at GMP auditors and those responsible for self-inspections, explaining the key points to observe in manufacturing sites, signs of potential issues, and precautions to avoid receiving criticisms. Participants will learn how to identify risks at manufacturing sites in advance within the limited audit time and how to concentrate audit resources based on risk. Topics covered include an overview of GMP, key points of administrative audits, legal requirements for supplier management, examples of audit checklists, supplier management flow, points for on-site tours, and QC/QA operations. Additionally, the seminar will discuss case studies based on the instructor's over 40 years of experience in manufacturing, actual instances of misconduct, 12 important matters to know in GMP operations, GMP audit manuals, the principle of "three realities," and organization and tidiness. *For more details, please check the related links or the seminar details in the catalog.*
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<Event Information> Format: Live Streaming (Zoom) / Archive Streaming Date and Time: 【LIVE Streaming】December 14, 2026 (Monday) 10:00 AM - 4:00 PM 【Archive Streaming】December 16 - December 30, 2026 (Application Deadline: December 25) Tuition Fee: 49,500 yen (tax included) Instructor: Takayuki Sone
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<Seminar Program (Tentative)> Chapter 1: Introduction to GMP Chapter 2: Key Points of Administrative Audits Chapter 3: Legal Requirements (Supplier Management) Chapter 4: Audit Checklists (Examples) Chapter 5: Supplier Management Flow Chapter 6: Key Points of On-Site Tours Chapter 7: QC/QA Operations (Examples) Chapter 8: Case Studies from Manufacturing Experience Chapter 9: Real Incidents of Fraud Chapter 10: 12 Essential Points to Know Before GMP Operations Chapter 11: GMP Audit Manual Chapter 12: Guaranteeing What You Have Verified Chapter 13: Organization and Tidiness as Fundamentals (Removal of Unnecessary Items, Horizontal and Right Angles) Chapter 14: References Chapter 15: Q&A Session
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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.
