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GlobalCompliancePanel, Online
March 4, 2010
This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Jeff Kasoff
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff has presented dozens of webinars in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
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Deadline for Abstracts:
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March 2, 2010
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Registration:
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Thursday, March 4, 2010
10:00 AM PST | 01:00 PM EST | | | Live live online training only for one participant | | |
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| | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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