The Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier 2014 is a webinar that covers topics such as:
- Required and desirable contents
- How to meet and document their differing requirements
- Similiarities and differences, and future convergences and trends
- Areas requiring frequent re-evaluation / update
- Typical Technical File or Design Dossier contents
- Typical DHF contents
- Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed
- The importance and usefulness of the "Essential Requirements"
- Where the Device Master Record / Device History Record "tie in"
- Parallel approaches to development
- Differing approaches to records audits by the U.S. FDA and an EU Notified Body
The Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier 2014 brings together:
- Middle management
- Senior management
- Engineering
- R&D
- QA / RA
- Software
- Operations
- Manufacturing
- CGMP instructors
- Consultants
- All personnel especially involved in device development, regulatory compliance and documentation
