Practical Training Course on Cultivating GMP Quality Culture through New Employee Education and OJT

The IR Institute of Technical Education will host an open seminar to learn practical educational know-how rooted in GMP operations, including guidance techniques for implementing work procedures and management standards in the field, troubleshooting strategies, and on-site inspection perspectives.

In pharmaceutical manufacturing environments, quality is not assured solely by documentation and systems, but is built into daily on-site operations.

At the same time, GMP regulations and concepts have become increasingly sophisticated and complex. Simply introducing systems such as CAPA or PDCA does not always ensure that practical capabilities are firmly established on the shop floor. In new employee education and on-the-job training (OJT), it is crucial not only to transfer knowledge but also to cultivate judgment and behavioral habits based on the principles of 'genchi, genbutsu, genjitsu'—the actual place, actual thing, and actual situation.

Seminar Overview

Seminar Title: 'Correct Coaching Methods' for On-Site Practitioners Responsible for GMP Training

Format: Online (Live Zoom Broadcast / Archive Access)

Schedule:

[Live Session] August 24, 2026 (Mon), 10:00–16:30

[Archive Access] August 26 – September 9, 2026

Fee: 49,500 JPY (tax included) per person (group enrollment discounts available)

Instructor: Takayuki Sone (Human Connector, GMP Consultant)

Course Details

This seminar will systematically cover foundational GMP knowledge and relevant regulations, methods of conducting theoretical, practical, and group training, and key points for on-site inspections in areas such as warehouses, storage areas, changing rooms, weighing rooms, filling rooms, testing laboratories, and packaging rooms. Furthermore, it will organize practical coaching methods to establish work procedures and management standards in the field and foster a quality culture, through topics such as essential information to convey before assigning new employees to the floor, learning from fraud case studies, error prevention, on-site QC/QA operations, and the D-OODA methodology.

Seminar Program

1. Introduction

　Self-introduction, key audit experiences

2. GMP Overview

　History of GMP, the three principles of GMP, hardware and software in GMP

3. GMP Training

　Legal requirements, theoretical training, practical training, general training, onboarding training, group training

4. Key Points for On-Site Inspections

　Warehouses and storage, changing rooms, receiving areas, weighing rooms, mixing rooms, filling rooms, testing laboratories, packaging rooms, finishing rooms, etc.

5. Preparing New Employees for Assignment to Pharmaceutical Manufacturing Sites

　GMP-related regulations, essential knowledge for new hires, document management, approaches to new employee training

6. Fraud Case Studies

　Lessons learned from audit findings, the progression leading to fraud discovery, and post-discovery responses

7. GMP Practical Operations

　Understanding job responsibilities, introduction to D-OODA, foreign material control in solid dosage forms, pest occurrence forecast calendar, importance of weighing,

　On-site QC/QA operations, etc.

8. Error Prevention

　General principles of error prevention and GMP-specific approaches

9. Conclusion

　How to walk the floor, key messages for training coordinators, reference materials, Q&A session

Target Audience

　Individuals responsible for GMP training

　Those in charge of new employee education

　OJT supervisors

　Professionals involved in training and coaching in pharmaceutical manufacturing environments

　Those facing challenges in implementing work procedures and management standards on-site

　Those seeking to refine their perspectives on on-site inspections and audit readiness

※ For more details about this seminar, visit:

https://nihon-ir.jp/seminar/gmp-teaching-methods_for-trainers/

The IR Institute of Technical Education will continue to provide practical knowledge and expertise through technical education services (seminars, e-learning, training, publishing) tailored for the manufacturing industry.

Nihon IR Inc.

With over 50 years of experience, the company offers patent and intellectual property solutions, along with technical information research and analysis, technical education for manufacturers, and technical content creation—delivering a wide range of highly specialized, technology-driven practical services.