Why Should You Attend:
The FDA Quality Systems Regulations for Medical Devices specifies certain documents or records that should be included in an organization's quality systems - Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR).
Are you maintaining adequate DHF, DMR and DHR 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? What happens when design, development or production is outsourced?
Attend this Webinar to have these questions answered
Many citations by the FDA include findings with respect to (i) insufficient or lack of information in the Design History File, (ii) incomplete or absence of any documentation of design verification and design validation, (iii) discrepancies between the final design outputs and the Device Master Record, (iv) not following the procedures to make the device as established in the DMR, and (v) incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR? 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, and provide examples for each one of them.
Areas Covered in the Seminar:
Who Will Benefit:This Webinar is designed for people involved in across all functions in the product development and production life cycle and for those who develop and write protocols and reports, and record and analyze data. This typically includes:
Dr. Vinny Sastri, Ph.D., is the President of WINOVIA® LLC and has over 25 years experience in new product development and quality management with a strong track record in the healthcare, medical device, electronics, plastics and the automotive industries. He is a certified Six Sigma black belt. WINOVIA assists companies increase their growth and profitability via customized solutions, strategies, training and implementation of effective, self-sustaining new product development and quality management processes. Areas of expertise include quality systems, product design and development, design controls, manufacturing and process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, risk management, CAPA and materials.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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