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CfPA-The Center for Professional Advancement, 90 Minute Accredited Online Training
November 13, 2014 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training will benefit medical device industry professionals in management, compliance, clinical research, regulatory affairs, research and development, and legal. This course would also be helpful for those who are new to the device industry or their position as well as to investors in
the device industry. Description
This course will be available On Demand: November 14, 2014
This 90-minute accredited online training course covers current FDA’s regulatory requirements for 510(k) premarket notifications. It includes an overview of the general premarket requirements and details the current 510(k) requirements. Among the topics discussed are strategic considerations in preparing a 510(k), when to submit a 510(k), and alternatives to the traditional 510(k) premarket notification. The course will also focus on current issues with the 510(k) program, review timelines, and proposed reforms to the 510(k) program.
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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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Jacqueline J. Chan, associate, K&L Gates LLP
Jacqueline J. Chan is an associate with the global law firm K&L Gates LLP. Ms. Chan’s practice focuses on FDA law and counseling regarding regulatory compliance and liability risks. She advises domestic and foreign pharmaceutical, device, food/food additive, cosmetic, dietary supplement, and tobacco clients on a broad range of matters including US labeling and promotional activities, enforcement risk assessment and defense, FDA submissions, post-marketing obligations, state regulatory compliance, and regulatory strategy development. Ms. Chan received her law degree from the George Washington University Law School and she received her BA with honors from the Johns Hopkins University.
Suzan Onel, Partner, K&L Gates LLP
Suzan Onel is a Partner at the global law firm K&L Gates LLP and Chairs the firm’s FDA practice. Ms. Onel advises on all aspects of FDA law and regulatory compliance across medical device, pharmaceutical, food, supplement, and cosmetic industries. She has extensive experience representing medical equipment, in vitro diagnostic, and biotechnology companies on a wide range of issues, including market entry strategies, premarket submissions (510(k)s, PMAs, IDEs), labeling and promotional activities, regulatory compliance, adverse event reporting, recalls and enforcement defense. She also regularly advises clients on the development of corporate compliance programs and regulatory strategy and conducts executive training sessions. Ms. Onel received her BA with honors in neurobiology and history from the University of Pennsylvania and her JD from the University of Virginia School of Law. She is also a frequent author and lecturer on FDA related topics.
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Deadline for Abstracts:
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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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