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    The 510(k): Its Purpose, Compilation, and Submission by John E.Lincoln

    View: 117

    Website https://compliance2go.com/product/?pid=CP2014-396 | Want to Edit it Edit Freely

    Category Biotechnology ; Medical Device ; Pharmaceutical

    Deadline: February 05, 2015 | Date: February 06, 2015

    Venue/Country: Online, U.S.A

    Updated: 2015-01-26 15:59:53 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

    The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based?. How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

    Areas Covered in the Session:

    FDA device clearance / approval

    FDA's and EUâ?™s emphasis

    Product changes and filing a new 510(k) who's responsible

    Tracking and evaluating changes the "tipping point"

    Is the process "risk based"?

    The FDA's "Decision Tree"

    Documenting the process / rationale

    Resolving a "wrong decision"

    Who Will Benefit:

    Senior management, project leaders, internal / external consultants

    Regulatory affairs

    Quality systems personnel / QAE

    R&D and engineering staff

    Personnel involved in Lean and Six Sigma Initiatives

    New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach

    CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of Attendance


    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.