Jeff Kasoff 2012 - Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?

Areas Covered in the Session:

- DMR and outsourced design/production

- DMR and OEM relationships

- Controlling and maintaining DMR

- Device History Record (DHR)

- Definition

- Contents

- Using DHR data for tracking and trending

- DHR and outsourced design/production

- DHR and OEM relationships

- Technical File (TF)

- Definition

- Contents

- TF and outsourced design/production

- TF and OEM relationship

- Design/process changes and DHF, DMR, DHR, and TF

Who will benefit:

This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:

Quality Managers/Engineers

Production/Process Managers/Engineers

Manufacturing Managers/Engineers

QA and QC managers, inspectors, supervisors and personnel

Documentation Specialists
Supplier Quality Managers/Engineers

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