Got News to Share? Send 2 FREE Releases ↓
All News Topics | Events By Topic | By Country | By State | By Date

DMR & DHR - What Is Really Required

Submit News
Date: 29-Feb-12 to 29-Feb-12
Location: OnlineWebinar / California / United States
Category: Healthcare & Pharmaceuticals

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
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.

Visitors

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

Exhibitors

At ComplianceOnline, we are focused on :
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, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible

enterprise, one which operates with high quality , under a code of ethics, and with process discipline to

ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our

processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions,

and regulatory agencies a voice so that all of us can contribute and make a difference

Go to event website