The Center for Professional Advancement, New Brunswick, NJ
November 14-16, 2007
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 PMA Supplements; 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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