Device Master Record & Device History Record – requirements, contents and implementation

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Why Should You Attend:

The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. These are Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures.

This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. This webinar provides the information about contents of the records and lessons for implementation.

Learning objectives:

• State the four major records required in FDA’s QSR.
• Describe the contents of the Design History File (DHF).
• Explain the source of the Device Master Record (DMR).
• Describe how the Device History Record (DHR) relates to the DMR.
• State the required content of the Quality system Record (QSR).
• Explain the difference between information if the DMR and the QSR.
• Understand the concept of a “designated individual” and the qualifications.

Areas Covered in the Seminar:

• The FDA’s QSR.
  • The source of the requirements
  • The preamble
  • The QSR Manual
  • OMB information collection
• Key Definitions
• Design History File (DHF).
  • Requirements
  • Content
• Quality System Record (QSR)
• Device Master Record (DMR)
  • Contents
  • Linkage to Design Controls
  • Lessons for Implementation
• Device History Record (DHR)
  • Contents
  • Linkage to the DMR
  • Lessons for Implementation

Related Technical Documents:

• 21 CFR Part 820 Quality System Regulation
• 21 CFR Part 820 Preamble (61 FR 52601, et seq.)
• Medical Device Quality Systems Manual: A Small Entity Compliance Guide
• Information collection for QSR, OMB No. 0910-0073

Who Will Benefit:

• Quality Managers
• Quality Professionals
• Regulatory Professionals
• Production Managers
• Risk Managers
• Project Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Document Control Specialists
• Record Retention Specialists