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CfPA - The Center for Professional Advancement, New Brunswick, NJ
April 11-13, 2011
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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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Suzan Onel, Esq.; Partner, K & L Gates LLP
Suzan Onel is a Partner in the global law firm K&L Gates LLP. Ms. Onel leads the device practice in Washington, DC and has two decades of experience in FDA-regulated matters. Ms. Onel's practice covers all issues related to FDA including food, drug, medical device, dietary supplements, and cosmetic law. She routinely counsels domestic and international companies on market entry strategies, premarket applications and notifications, labeling, promotional activities, regulatory compliance, due diligence investigations, recalls, and enforcement defense. Ms. Onel's experience includes extensive interaction with the U.S. Food and Drug Administration, the Federal Trade Commission, the Consumer Product Safety Commission, the National Advertising Division of the Better Business Bureaus, and similar state and international bodies. She is a frequent author and lecturer on FDA matters including combination products, medical device software, dietary supplements, and functional foods. She received her Bachelors degree with honors in neurobiology and history from the University of Pennsylvania and her law degree from the University of Virginia School of Law.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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