Webinar on “Design History File and Device Master Record - Regulatory Documents Explained”
10/18/2012

GlobalCompliancePanel, will organize Raps pre approved webinars on “Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) –Regulatory Documents Explained”, on November 8.

Online PR News – 18-October-2012 – Wilmington – Description:
Documentation is a very critical aspect of a medical device’s design. A measure of its importance can be gauged by the fact that giving insufficient information in the Design History File (DHF), or not following the procedures in making the device in accordance with what is established in the Device Master Record (DMR), or furnishing incomplete or inaccurate production data of incoming, in-process and finished products is a reason for an FDA citation.
Some of the typical questions that a medical device manufacturer faces are: Can Iprepare and access all documents that detail the design of my device? Am I following the right steps in writing my DMR, and is it accurate? This webinar will address this and many other related questions and doubts.
This webinar will familiarize participants with what information to put in the Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF), which are documents and records that need to be a part of a medical device organization’s quality systems.
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When: November 8, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. In this position, Jeff holds the critical portfolio of being responsible for oversight of corporate compliance with domestic and international regulations and preparation of submissions, and is the primary liaison point with regulatory agencies and notified bodies.
Performing such challenging tasks day in and day out has given Jeff deep knowledge of regulatory affairs, which he has imparted in the dozens of webinars he has presented in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Delivering on challenges has thus never been new to Jeff. Jeff received his Regulatory Affairs Certification in 1996.
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For whom:
o Quality Managers/Engineers
o Production/Process Managers/Engineers
o Manufacturing Managers/Engineers
o QA and QC managers, inspectors, supervisors and personnel
o Documentation Specialists
o Supplier Quality Managers/Engineers
o Regulatory Managers/Engineers
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407