Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA? If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.
RAPS Approved Webinar on Device Corrections and Removals Date & Time: Course "Device Corrections and Removals" has been pre- approved by RAPS as eligible for up to 1.5 credits towards a Register Now participant's RAC recertification upon full completion. Instructor Profile: Thursday, August 30, 2012 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: Dan OLeary Dan OLeary President, Ombu Enterprises Location: Online Price : $245.00 (for one participant) Dan is the President of Ombu Overview: Enterprises, LLC, a company offering training and execution in Operational When your firm finds a problem with one of the devices you already Excellence, focused on analytic skills shipped, fix it for the customer. Do you report it to the FDA? and a systems approach to operations management. Dan has If you send a letter to a customer that says, "We found a problem, more than 30 years experience in but, not to worry, we will fix it for you!", you may have invoked the quality, operations, and program Corrections and Removals process. Under Part 806 of the FDA management in regulated industries regulations, you must report this event to FDA. including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is Under certain circumstances, you may not need to report, but you an ASQ certified Biomedical Auditor, must keep a record of your decision. You need to make sure you Quality Auditor, Quality Engineer, know the when to report and when a record is adequate. Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management. ...more Areas Covered in the Session: l The basic requirements of Part 806 Suggest a Topic More Webinars l When to report l Exemptions that you may apply Your Necessity is our Priority ¡ Market withdrawal ¡ Routine servicing ¡ Stock recovery ¡ Reporting under Part 803 – Medical Device Reports ¡ Reporting under Part 1004 – Repurchase, Repairs, or Replacement of Electronic Products l The requirements of a report and the timing l The requirements for records when you don’t report l The expectations of a QSIT Inspection l Elements of a robust system l How to check your system for compliance l Recalls l Design changes and potential 510(k) submissions ¡ The current guidance ¡ The draft guidance Click here to register for this webinar Who Will Benefit: l Quality Professionals l Regulatory Professionals l Risk Management Specialists l Complaint Managers and Specialists l Compliance Officers l General/Corporate Counsel l Regulatory/Legislative Affairs Professionals It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel 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. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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