Topics
- Subject Areas covered
- Valuable documents that provide understanding
- QSR Preamble
- Quality System Regulation (QSR), including the definitions
- FDA`s Quality System Inspection Technique (QSIT) manual
- ISO 13485:2003
- Warning Letters
- Organization
- Quality policy
- Resources
- Responsibility and authority
- Management review
- Management Representative
- Quality system procedures
- Quality planning
Who should Attend
Device company Managers, Device Company Executives, Regulatory Affairs Managers, Quality Managers, Management Representatives, Risk Managers, Design Engineering Managers and Production Managers.
