Live webinar on Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained By Compliance2go August 9, 2012

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


About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996.