This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.
The webinar will also help you understand some very important related documents. The Design History File (DHF) is part of the design project, and does not duplicate the DMR. The webinar will help you understand the difference. In addition, the Quality System Record (QSR) can be a valuable adjunct to the DMR. The speaker will advise you on when to put device information into the QSR.
The contents of the DHR are in 21 CFR §820.184, or so it seems. Unfortunately, there are additional DHR requirements spread throughout the regulation. For example, disposition of nonconforming material can impact the DHR as well as records (produced by designated individuals) of the primary labels. This webinar compiles these additional requirements and explains them.
People in the following roles can especially benefit from the knowledge in this webinar:
Why Should You Attend:
Have you ever been confused about what needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and assemble a complaint DMR and use it to build your DHR.The webinar will also help you understand some very important related documents. The Design History File (DHF) is part of the design project, and does not duplicate the DMR. The webinar will help you understand the difference. In addition, the Quality System Record (QSR) can be a valuable adjunct to the DMR. The speaker will advise you on when to put device information into the QSR.
The contents of the DHR are in 21 CFR §820.184, or so it seems. Unfortunately, there are additional DHR requirements spread throughout the regulation. For example, disposition of nonconforming material can impact the DHR as well as records (produced by designated individuals) of the primary labels. This webinar compiles these additional requirements and explains them.
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:
This webinar is for people involved in project management, design, production, purchasing, installation, servicing, document control, and record keeping activities for medical device manufacturing.People in the following roles can especially benefit from the knowledge in this webinar:
- 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
Course Provider
Daniel O Leary,
