Medical Device Regulatory Compliance
November 02 - 04, 2009
New Brunswick, NJ
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Who Should Attend
Because of its comprehensive overview, this course will
be most valuable to medical device industry professionals in:
• Management
• Regulatory Affairs
• Compliance
• Research and Development
• Quality Assurance
• Quality Control
• Clinical Research
The course will also be helpful for those who are new to the
industry or to their current position and do not have an indepth
knowledge of the FDA and its workings; as well as for
more experienced personnel, including middle and upper
management, to update and broaden their knowledge of FDA
requirements.
Description
This continually updated course covers current FDA
regulatory compliance issues with respect to developing,
manufacturing, and marketing medical devices. It includes an
overview of the FD&C Act, case law, and pertinent FDA
regulations. Among the many topics to be discussed will be:
FDA’s regulatory policies, how they develop and where they
are documented; potential FDA enforcement for
noncompliance including warning letters, injunctions, seizures,
civil penalties, and criminal prosecutions; device classification
and reclassification; premarket submissions requirements for
510(k)s, IDEs, PMAs, and combination products; device
promotion and advertising; post market requirements
including establishment registration, device listing, and
adverse event reporting; inspections; recalls; and the QSR,
including design controls and process validation. The course
will focus on the application of the law, regulations, and
policies to medical devices.
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