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Live Webinar Device Corrections and Removals Date: Thu, December 18, 2014 Instructor:Dan OLeary
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 90 Minutes
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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.
Areas covered in the session: The basic requirements of Part 806 When to report Exemptions that you may apply ¡ Market withdrawal ¡ Routine servicing ¡ Stock recovery ¡ Reporting under Part 803 - Medical Device Reports ¡ Reporting under Part 1004 - Repurchase, Repairs, or Replacement of Electronic Products The requirements of a report and the timing The requirements for records when you don’t report The expectations of a QSIT Inspection Elements of a robust system How to check your system for compliance Recalls Design changes and potential 510(k) submissions ¡ The current guidance ¡ The draft guidanc
Who Will Benefit: Quality Professionals Regulatory Professionals Risk Management Specialists Complaint Managers and Specialists Compliance Officers General/Corporate Counsel Regulatory/Legislative Affairs Professionals
About Speaker Dan OLeary President, Ombu Enterprises Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in
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