Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR
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Website https://compliance2go.com/product/?pid=CP2014-354 |
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Category Medical Device
Deadline: October 23, 2014 | Date: October 23, 2014
Venue/Country: Online, U.S.A
Updated: 2014-09-11 20:59:55 (GMT+9)
Call For Papers - CFP
DESCRIPTIONDevice manufacturers are required to establish and maintain a quality management system, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements including DHF, DHR and DMR. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.Areas To Be Covered in this Webinar:Federal Statutes and Regulations Governing Medical Devices in the USIntroduction and DefinitionsDesign and Development PlanningDesign InputDesign OutputDesign ReviewDesign Verification And Validation including Software ValidationDesign TransferDesign ChangesDesign History File (DHF)Device History Record (DHR)Device Master Record (DMR)Enforcement ActionsSpeaker’s PASS-IT recommendations/suggestionsWho will benefit:R&D Scientists, Engineers, Managers, and DirectorsRegulatory AffairsQuality ProfessionalsProduct Development ProfessionalsCROsConsultantsSenior ManagementContractors and SubcontractorsAnyone interested in the subjectWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides60 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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