To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field.
Live Webinar on Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements Course "Efficient Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements" has been pre- Register Now approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Date & Time: Instructor Profile: Wednesday, June 27, 2012 10:00 AM PDT | 01:00 PM EDT Jeff Kasoff Duration: 60 Minutes Instructor: Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Location: Online Price : $245.00 (for one participant) Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading Overview: manufacturer of endoscopy and To satisfy QSR and ISO 13485 requirements, medical device colonoscopy devices, where he companies must respond to field reports swiftly and compliantly. oversees the operation of the quality There are certain circumstances in which a report from the field system. In this position, Jeff is responsible for oversight of the requires the device manufacturer to take steps regarding product in document control system, including the field. maintenance of regulatory documentation. Prior to this, Jeff It is critical that the company take the required steps in the required spent 13 years at Life-Tech, Inc. as timeframes. FDA and ISO requirements overlap to a great extent, but the Director of Regulatory Affairs, not completely. This webinar sets forth the requirements for recalls, where he was responsible for removals, and market corrections, and provides recommended compliance of the corporate quality practices. system. Jeff received his regulatory affairs certification in 1996. ...more Why should you attend: There are certain circumstances in which a report from the field Suggest a Topic More Webinars requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the Your Necessity is our Priority required timeframes. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship product. Areas Covered in the Session: l Regulatory definitions of recalls, removals, and market corrections l Instances which require recalls, removals, or market corrections l What to do during recalls, removals, and market corrections l Recordkeeping requirements for recalls, removals, and market corrections l ISO 13485-specific requirements l CMD-specific requirements (Canadian device regulations) Click here to register for this webinar Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include: l Regulatory Management l Quality Assurance Professionals l Consultants l Sales/Marketing Management l Senior and mid-level Management l Quality System Auditors 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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