DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them 2012

Topics

• 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

Who should Attend

R&D Personnel/Management, Document Control Personnel, Senior Management and Regulatory Affairs Management.