Live webinar Special Considerations during Medical Device Design: Dos and Don'ts
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Website https://compliance2go.com/product/?pid=CP2014-392 |
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Category Biotechnology , Medical Device
Deadline: November 26, 2014 | Date: November 26, 2014
Venue/Country: Houston, U.S.A
Updated: 2014-11-05 16:47:37 (GMT+9)
Call For Papers - CFP
DESCRIPTIONThis webinar is intended to discuss important aspects of medical device design and development. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), a medical device firm is subject to design control requirements, to the extent applicable during development including clinical trials and postmarketing. Based on the FDA enforcement trends, design control failure are frequently cited in 483s and FDA warning letters.FDA warning letters state “Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met.”In addition, due to device design control failures, it has resulted in many device recalls.This webinar is intended to provide guidance on what key considerations should be focused during medical device development under the surrounding circumstances. It is also intended to provide further guidance on how to establish and maintain design control procedures in a way to survive an FDA inspection applicable for all classes of medical devices including IVDs.In particular, this webinar will discuss various device design failures as examples to greatly In particular, this webinar will discuss various device design failures as examples to greatly increase our awareness.It should be noted that an adequate understanding, interpretation, and implementation of design control system requirements in a holistic manner can significantly contribute to your product quality and regulatory compliance, helping to ensure your innovative medical products safe and effective on a global market. As a result, your adequate implementation of design control will significantly contribute to saving an enormous amount of your unnecessary time, efforts and investment for a long term.This webinar is a must for medical device and IVD firms conceptualizing, developing and marketing medical devices including anyone interested in the topics from other industry. This webinar will provide great opportunities to streamline device design and development process including regulatory approval/clearances and postmarketing. Why Should you AttendYou need to ask sets of questions during medical device concept phase for developing intended use/user needs.It is important to ensure you are familiar with the regulatory requirements applicable for medical device design and development.Based on the regulatory requirements, firms shall establish and maintain adequate medical device design control procedures. Areas Covered in the WebinarStatutes and RegulationsDevice Design ConceptDefinitionsDesign and Development PlanningKey ConsiderationsDesign Control System ComponentsDesign Control Sub-SystemsDesign Input and Design OutputDesign ReviewDesign V and/or VDesign Transfer and Design ChangesDesign History File (DHF), Device History Record (DHR) and Device Master Record (DMR)Common Mistakes and How to AvoidHow to Prepare for FDA inspection for Design ControlBest Practices based on Actual CasesSpeaker’s Recommendation and Suggestions on PASS-IT SolutionsWho will Benefit: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 personnelConsultantsContractors/subcontractorsCEOsVPsClinical affairs (associates, specialists, managers, directors or VPs)Other interested partiesWebinar 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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