Make 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. The CD is based on a webcast which took place on January 14th 2009.
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 Ordiances - 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
Product samples
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