Sign for Notice Everyday    Sign Up| Sign In| Link| English|

Our Sponsors

    Receive Latest News

    Feedburner
    Share Us


    A straightforward method for meeting FDA Requirements for Design Inputs and Outputs

    View: 143

    Website http://www.traininng.com/webinar/the-diom---a-straightforward-method-for-meeting-fda-requirements-fo | Want to Edit it Edit Freely

    Category Educational trainings, HR professionals, Human Resource, Online trainings, Employee Relations

    Deadline: November 16, 2019 | Date: November 18, 2019

    Venue/Country: Online, U.S.A

    Updated: 2019-09-20 14:28:05 (GMT+9)

    Call For Papers - CFP

    Overview

    A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to help identify and categorize design inputs, determine the most effective method in providing design output evidence, and showing traceability to all activities associated with both.

    The speaker has worked on numerous design development projects in Class II and Class III medical devices as well as establishing Quality Management Systems which include easy-to-understand methods to meet design development and design control requirements. This webinar will walk you through step-by-step how to complete a DIOM for your product and simplify this often overly complex process.

    Why should you Attend

    Better understanding of FDA regulations with regards to design input and output

    An organized approach in meeting design input and output requirements

    A simplified way to ensure design inputs and outputs are continually maintained and tracked

    Areas Covered in the Session

    Introduction to the DIOM template

    How to identify your design inputs

    How to categorize your design inputs and their sources

    Ways in which design inputs can be verified

    Common documents and activities used as design output evidence

    Additional requirements of design inputs and outputs

    Who Will Benefit

    Quality Assurance

    Regulatory Affairs

    Design Engineers

    Manufacturing Engineers

    Startup Companies

    Speaker Profile

    Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.