Why Should You Attend:
Have you ever been confused about what needs to be in your Device Master Record (DMR) and your Device History Record (DHR)? This webinar will help you understand the requirements and assemble a complaint DMR and use it to build your DHR.
The webinar will also help you understand some very important related documents. The Design History File (DHF) is part of the design project, and does not duplicate the DMR. The webinar will help you understand the difference. In addition, the Quality System Record (QSR) can be a valuable adjunct to the DMR. The speaker will advise you on when to put device information into the QSR.
The contents of the DHR are in 21 CFR §820.184, or so it seems. Unfortunately, there are additional DHR requirements spread throughout the regulation. For example, disposition of nonconforming material can impact the DHR as well as records (produced by designated individuals) of the primary labels. This webinar compiles these additional requirements and explains them.
Areas Covered in the Seminar:
Related Technical Documents:
Who Will Benefit:This webinar is for people involved in project management, design, production, purchasing, installation, servicing, document control, and record keeping activities for medical device manufacturing.
Daniel O'Leary, 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. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
The FDA's QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents.
The four sets of documents fit together in a structure that helps assure correct device manufacturing. The content of the documents and the allocation of information depends on your manufacturing system; you should tailor the approach to your company’s products and approaches.
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