DMR & DHR - What Is Really Required

Dec. 16, 2011 - PRLog -- 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.

For  Registration:
http://www.complianceonline.com/ecommerce/control/trainin...

# # #

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.