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Design History File (DHF) Device Master Record (DMR) Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained

Date & Time: Thursday, August 25, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Jeff Kasoff

Location: Online

Price : $245.00

 

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(for one participant)

Instructor Profile:

Overview:

Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc

This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well.

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 reviews and approves supplier qualification, selection, assessment, and CAPA. 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. ...more

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, inprocess and finished products.

Why you should attend: The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Do you know what information should reside in a DHF, a DMR and a DHR? This Webinar will define, explain and clarify the different records.

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Areas Covered in the Session:

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FDA Quality Systems Regulation Requirements/Definitions

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MDD Requirements/Definitions Design History File (DHF) ¡ Definition ¡ Typical contents Device Master Record (DMR) ¡ Definition ¡ Typical contents ¡ Controlling and maintaining DMR Device History Record (DHR) ¡ Definition ¡ Contents ¡ Using DHR data for tracking and trending Technical File (TF) ¡ Definition ¡ Contents

Design/process changes and DHF, DMR, DHR, and TF

Click here to register for this webinar Who Will Benefit: This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to market in the EU as well. The employees who will benefit include: l l l l l l

Quality Managers/Engineers Production/Process Managers/Engineers Manufacturing Managers/Engineers QA and QC managers, inspectors, supervisors and personnel Documentation Specialists Supplier Quality Managers/Engineers


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Regulatory Managers/Engineers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

Design History File Regulatory DocumentsExplained  

This webinar will provide valuable assistance to all device manufacturers, those who market solely within the US, or those who wish to marke...

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