PrintMake sure you are prepared for your Japan medical device registration by fully understanding the QMS auditing process. Audits can either consist of a document review or an on-site inspection. This presentation describes how to prepare for your audit and what the process entails.
This 90-minute session includes a 60-minute presentation, followed by 30 minutes of Q&A. The speaker is Ames Gross, president of Pacific Bridge Medical.
See a sample page (PDF) from this webcast presentation.
What you will learn:
- Introduction to Japan
- Demographics
- Medical Markets
- What is a Japanese QMS audit?
- Why is it required?
- When does it occur during the product registration process?
- Types of audits
- Pre-approval compliance audits
- Post-approval compliance audits
- Others
- Corporate structure of MAH to comply with QMS
- What are the regulations that affect a QMS audit?
- Pharmaceutical Affairs Law
- Ministerial Ordinances
- Legislative Decrees
- ISO vs. QMS
- Who will be audited?
- Which government agency/regulatory authority will perform the audit?
- Audit on-site or document review?
- What do you need to do prior to a physical audit?
- Documents to prepare for the audit
- Information to submit before audit
- What documents and systems will be audited when the auditors arrive?
- Points to be inspected:
- QMS Manual
- SOPs
- Seihin Hyojun Sho
- Device History Record
- What other things will you need to do during the audit?
- What to watch for during the audit/potential pitfalls?
- After Audit
- PMDA grading system
- Non-conformity issues
- Tips for success
- Renewing your QMS
- Cross-cultural issues
- Japanese values
- Japanese etiquette
