Pack of THREE: Best Selling 510(k) Webinars by GlobalCompliancePanel Actual Price:
The 510(k) Submission: Requirements, Contents, and Options
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.
Device Changes and the 510(k)
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.
The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
FDA's New Draft Guidance on Medical Device Changes and the 510(k)
This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510 (k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) one major change to an existing product having an existing 510(k), for the need for a new 510(k).
Click here to buy the webinar pack Instructors: John E Lincoln
Consultant, Medical device and Regulatory Affairs
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk
management, U.S. FDA responses. ..mo
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. .. more
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About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals.
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