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 will describe how to prepare for your audit and what the process entails. This 90-minute webcast CD includes a 60-minute presentation, followed by a 30-minute recorded Q&A.
See a sample page of our webcast presentation.
- What is a Japanese QMS audit?
- Types of Audits
- QMS inspection types
- Purpose of audit
- Corporate structure of MAH to comply with QMS
- Which Agency will conduct audit?
- Documents to prepare for audit
- Medical device classifications
- QMS regulations in PAL
- QMS related Laws and Ordinances
- QMS audit by regulators
- On-site versus document review?
- Pre-approval compliance audit
- Post-approval compliance audit
- ISO vs. QMS
- Device Master Record
- Audit Process/Schedule
- What items will be reviewed
- PMDA grading system
- Tips for success
- Cross-cultural issues