Webinar Pack
Pack of THREE: Best Selling DHF-DMR-DHR Webinars by GlobalCompliancePanel Actual Price:
$885.00
Your Price:
$495.00
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DHF, DMR, DHR, Technical File and Design Dossier Key Requirements and Future Directions This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Instructors: John E Lincoln Consultant, Medical device and Regulatory Affairs
It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed.
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. ..more
Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained 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).
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.
Device Master Record & Device History Record The FDA's Quality System Regulation (QSR) requires each device manufacturer to compile the specifications and procedures for a medical device. The manufacturer must also compile records of the production history of the device. These two sets of records (DMR & DHR) are complimentary. In addition, the manufacturer maintains two more sets of documents, the Design History File (DHF) and the Quality System Record (QSR). This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA’s thinking, FDA guidance documents for recommendations, and Warning Letters to help participants learn from other firm’s experience. The FDA's QSR
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products... more
Dan OLeary President, Ombu Enterprises
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. .. more
expects the manufacturer to maintain a series of documents that describe the design and production of the device. Your Necessity is our Priority
Click here to buy the webinar pack 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
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