Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR by compliance2go
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Website https://compliance2go.com/product/?pid=CP2014-441 |
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Category Medical Device
Deadline: May 11, 2015 | Date: May 12, 2015
Venue/Country: Online, U.S.A
Updated: 2015-03-26 21:03:27 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis webinar is intended to help you get familiar with an FDA-compliant design control system including a UDI system integration. Device manufacturers are required to establish and maintain the FDA-compliant design control system, where appropriate and applicable, as part of the quality management systems (QMS). Understanding, interpreting, and implementing design control requirements in a CAC-SI manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving an enormous amount of your unnecessary time and efforts including financial resources. This webinar will provide great opportunities to learn practical, actionable, and sustainable guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures applicable for all different types of medical devices including IVDs.At the end of the webinar, you will learn the best practices for design control requirements including DHF, DHR, and DMR and the UDI system integration in a manner you would establish and maintain the design control processes in a more efficient and effective manner. Why should you attend :This webinar will provide opportunities to get better familiar with an FDA-Compliant Design Control for Medical Devices Including In Vitro Diagnostic Medical Devices (IVDs).Areas Covered in the Session:Laws and Regulations Governing Medical Devices including IVDsDefinitionsRequirements for Design and Development PlanningRequirements for Design Input, Design Output and Design ReviewDesign Verification And Validation including Software ValidationDesign TransferDesign ChangesDesign History File (DHF)Device History Record (DHR)Device Master Record (DMR)Integrating a UDI System into the Design ControlSpeaker’s PASS-IT Recommendation/SuggestionsConclusionWho will benefit: (Titles)CEOsVPsClinical affairs (associates, specialists, managers, directors or VPs)Regulatory affairs (associates, specialists, managers, directors or VPs)Quality professionals (associates, specialists, managers, directors or VPs)R&D (engineers, scientists, managers, directors or VPs)Complaint and risk management personnelConsultantsAnyone interested in the topicsWebinar Includes:Q/A Session with the Expert to ask your questionCopy of PowerPoint slides (PDF print only)60 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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