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Live Webinar Device Changes, FDA Changes, and the 510(k) Date: Tue, December 16, 2014 Instructor: John E Lincoln
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 60 Minutes
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Course "Device Changes, FDA 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.
Overview: 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".
Areas covered in the session: U.S. FDA device clearance / approval FDA's and EU'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"? K-97-1 and 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.
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About Speaker John E Lincoln Consultant, Medical device and Regulatory affairs, John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peerreviewed technical articles, and workshops, world wide.
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