Duration

2-day

Training Venue

WCCQ training centre in Kowloon Bay  (Hong Kong)

Language

Cantonese with Chinese / English materials

Description

This course aims to provide students who have an existing basic knowledge of, or experience in, medical device quality management. With an understanding of the management systems approach and the requirements of JGMP and to provide a solid information for students to become JGMP internal auditor. 

Learning Outcomes

- Understand and explain the purpose and benefits of JGMP Requirements toward medical device manufacturer

- Understand and outline the structure and content of JGMP and its relationship with ISO13485.

- Understand and explain the specific quality management-related requirements of JGMP 

Agenda / Content

- Introduction of Japan Medical Device Regulation and its core concept

- Explanation of the JGMP requirements and relationship to ISO13485, including risk management, process validation requirements, vigilance system etc.

- Guidance on the benefits of building on foundation for internal audit of JGMP

- Assignment (this course is 50% activity base)

- Delegate Assessment 

Participants

The course is intended for all those - Medical device professionals with knowledge of quality management systems and ISO 13485

- Individuals interested in conducting first-party or second-party audits related to JGMP requirements

- Individual who interest to develop JGMP medical device quality management system within company

- JGMP Internal auditors 

Pre-requisites

The students are recommended to have the following prior knowledge before attending this course:

- Knowledge of ISO13485 management systems

- Knowledge of medical device quality management, consisting of:

- A basic knowledge of the concepts of medical device quality management and the relationship between quality management and related regulatory requirements

- A basic understanding of medical device knowledge or working on the medical device industry.

Learning Method

Lecture, case studies and assignment

Contact information

For further information or discussion on analyzing and meeting your training needs please contact us at certificates@wccq.org or (852) 2110 8492. 

Remarks

# Onsite training quotation is available: please contact us for an on-site proposal. We respond to inquiries on the same day.