Introduction to the Japanese Pharmaceutical and Medical Device Act for Internal Auditors
Maintaining regulatory compliance for medical devices in Japan requires you to conduct internal audits to monitor your on-going compliance. It's important to understand the requirements to conduct a successful audit.
Optimize your auditing skills with a deeper insight of Japanese Pharmaceutical and Medical Device Act and learn what to look for in a Quality Management System (QMS) that is compliant with ISO 13485.
Who should attend?
- Quality Managers
- Internal Auditors
- Regulatory Affairs Managers
Note: Knowledge of the Japanese PMD Act is a pre-requisite for this course.
What will I learn?
You will learn about:
- PMD Act and Welfare Ministerial Ordinance No. 169 requirements
- What points to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485
How will I benefit?
This course will help you:
- Prepare, conduct and follow-up on ISO 13485 compliant QMS audit activities
- Gain the skills to assess an organization’s capability to manage its quality management system
- Offer confidence to customers and suppliers that a device meets regulatory requirements
- Write factual audit reports and suggest corrective actions
- Enhance customer satisfaction though effective audit application and commitment to continual improvement.
- Training course notes