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WebOct 11, 2011 · Dengue viruses (DENV) are the causative agents of dengue fever (DF) and dengue hemorrhagic fever (DHF). Here we review the current state of knowledge about the human antibody response to dengue and identify important knowledge gaps. A large body of work has demonstrated that antibodies can neutralize or enhance DENV infection. … The requirements for a design history file (DHF) are found in 21 CFR 820.30j: “Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the … See more The article does not include a DHF template, but recommendations for format and content of a design history file are provided. A couple of weeks ago I announced that I will … See more The DHF is is intended to provide evidence of following an approved design plan, but the DHF consists of many records–not just one … See more If you are interested in learning more about design history files, there is still time to register for today’s live training webinar. For a cost of $129 you will receive: 1. a link to join the live webinar @ 10am EDT 2. a native slide deck … See more Product design changes that occur prior to the final design review and approval of commercial release are required for inclusion in the DHF. However, once a product is released the control over design changes should be … See more philz nutrition facts
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