DHF, DMR, DHR and TF - Regulatory Documents Explained 2013

Topics

• Design History File (DHF): Definition, Typical contents, DHF and outsourced design/production, DHF and OEM relationships
• FDA and MDD definitions/requirements
• Device History Record (DHR): Definition, Contents, Using DHR data for tracking and trending, DHR and outsourced design/production, DHR and OEM relationships
• Device Master Record (DMR): Definition, Typical contents, DMR and outsourced design/production, DMR and OEM relationships, Controlling and maintaining DMR
• Technical File (TF): Definition, Contents , TF and outsourced design/production, TF and OEM relationship

Who should Attend

• Production/Process Managers/Engineers
• Quality Managers/Engineers
• QA and QC managers, inspectors, supervisors and personnel
• Manufacturing Managers/Engineers
• Supplier Quality Managers/Engineers
• Documentation Specialists
• Regulatory Managers/Engineers