PrintThis webcast CD provides an overview of Pharmaceuticals and Medical Devices Agency (PMDA) inspections of foreign device manufacturers and foreign device manufacturer accreditation system in Japan. This Japanese presentation has 61 PowerPoint slides. The speaker is Dr. Masaka.
See a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Who will be inspected
- What medical device classes must be inspected
- How much prior notice there will be
- What items will be reviewed during the audit
- How to treat inspectors
- The best ways to prepare for the audit
- When problems develop during the audit, and how to respond
- What will happen after the audit
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on Japanese auditing procedures.
Our speaker is Dr. Masaka, PBM's partner in Japan. She has over twenty years of experience in Japanese medical device regulatory affairs.