DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them 2012 is a seminar that covers topics such as:
- DHR - Device History Records
DHR Requirements – Regulation, Definition, DHR Purpose – Manufacturer, DHR Contents, DHR Requirements and DHR Purpose – FDA - Device Master Record
DMR Contents and Description - Technical File
Structure – Detail, Structure – Outline, Risk Analysis, Essential Requirements Checklist and Clinical Requirements - Design History File
Rationale, Regulatory Requirements and DHF Contents - Document Retention Change Control for Design Documentation
Risk Assessment and Design History File - Document Control
FDA Requirements, Regulatory History, Document Approval, ISO 13485 Requirements, Document Distribution, Document Control, Streamlined Document Control Process, Typical Document Control System and How to handle "Minor" changes - Change Control Considerations
Purchasing Controls, Management Controls and Production Controls
DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them 2012 brings together R&D Personnel/Management, Document Control Personnel, Senior Management and Regulatory Affairs Management.
