Device Changes and the 510(k)

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    Live Webinar         on
     Device Changes and the 510(k)

     Course "Device Changes and the 510(k)" has been pre-
     approved by RAPS as eligible for up to 1.5 credits towards a
     participant's RAC recertification upon full completion.
                                                                                                 Register Now                         

    Date & Time:
                                                                                           Instructor Profile:
     Wednesday, May 9, 2012             10:00 AM PDT | 01:00 PM EDT

     Duration: 90 Minutes               Instructor: John E Lincoln                                     John E Lincoln
                                                                                                   Consultant, Medical device
     Location: Online                   Price : $245.00   (for one participant)
                                                                                                    and Regulatory affairs,

                                                                                           John E. Lincoln is a medical device
                                                                                           and regulatory affairs consultant. He
    The majority of medical devices are cleared for marketing in the U.S.                  has helped companies to implement
    by the FDA under the 510(k) process.                                                   or modify their GMP systems and
                                                                                           procedures, product risk
    The FDA holds companies responsible for filing new 510(k)s when                        management, U.S. FDA responses.
                                                                                           In addition, he has successfully
    one change is major enough to impact safety / effectiveness, or
                                                                                           designed, written and run all types of
    when a series of lesser changes finally reach the "tipping point". This
                                                                                           process, equipment and software
    is a major headache. How can companies make that determination?                        qualifications/validations, which have
    How can they trigger such an analysis over the major change or the                     passed FDA audit or submission
    series of smaller changes. What approaches are required for product                    scrutiny, and described in peer-
    changes; for process changes. How is the process risk-based? How                       reviewed technical articles, and
    to maximize the process against scarce resources. What are the                         workshops, world wide. John has
    different considerations for CE-marked product?                                        also managed pilot production,
                                                                                           regulatory affairs, product
                                                                                           development/design control, 510(k)
    Areas Covered in the Session:                                                          submissions, risk management per
                                                                                           ISO 14971, and projects; with over
                                                                                           28 years of experience in the FDA-
       l   U.S. FDA device clearance / approval
                                                                                           regulated medical products industry
       l   FDA's and EU's emphasis                                                         - working with start-ups to Fortune
       l   Product changes and filing a new 510(k) – who's responsible                     100 companies, including Abbott
       l   Tracking and evaluating changes – the "tipping point"                           Laboratories, Hospira,
       l   Is the process "risk based"?                                                    Tyco/Mallinckrodt. He is a graduate
       l   K-97-1 and the FDA's "Decision Tree"                                            of UCLA. ...more
       l   Documenting the process / rationale
       l   Resolving a "wrong decision"
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    Who Will Benefit:

       l   Senior Management, Project Leaders, Internal / External
       l   Regulatory Affairs
       l   Quality Systems Personnel / QAE
       l   R&D and Engineering Staff
       l   Personnel involved in Lean and Six Sigma Initiatives
       l   New product development, regulatory submissions, driving
           company-wide quality initiatives, under a risk-justified
       l   CAPA personnel desiring to minimize post-production / life
           cycle, root cause investigation, and other costly problems.

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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