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.

What's included?

  • Training course notes
  • Lunch