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global compliance panel, Online Training Webinar
2011-08-25
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. Are you maintaining adequate DHF, DMR, DHR, and TF records? Do you know what data and information need to reside and where does it reside? Are your records easily accessible? Are you confused by these terms? Attend this Webinar to have these questions answered.
Areas Covered in the Session: FDA Quality Systems Regulation Requirements/Definitions- 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)
- Design/process changes and DHF, DMR, DHR, and TF
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:- Quality Managers/Engineers
- Production/Process Managers/Engineers
- Manufacturing Managers/Engineers
- QA and QC managers, inspectors, supervisors and personnel
- Documentation Specialists
- Supplier Quality Managers/Engineers
- Regulatory Managers/Engineers
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Organized by:
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global compliance panel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2011-08-25
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884 2011-08-25
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E-mail:
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webinars@globalcompliancepanel.com
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