Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.
Toll Free Number: 800-447-9407 Live Webinar on Complaint Handling in Compliance with FDA and ISO Regulations Date: Tuesday, March 5, 2013 Time: 10:00 AM PST | 01:00 PM EST Course "Complaint Handling in Compliance with FDA Duration: 60 Minutes and ISO Regulations" has been pre-approved by Instructor: Jeff Kasoff RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion. Location: Online Jeff Kasoff Director of Regulatory Affairs, Register Now Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. ...more Overview: Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s. This session will include the requirements for defining, documenting, and implementing a complaint- handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. Areas covered in the session: l FDA and ISO requirements for complaint handling l Establishment of complaint handling program l What constitutes a complaint l ISO-specific implications of complaint handling l The roles of investigation and corrective action in complaint handling l Complaint trending and reporting l Application of risk management to complaint handling program Who Will Benefit: Suggest a Topic l Regulatory Management More Webinars l Quality Management l Customer Service Personnel l Sales Personnel l Quality System Auditors Click here to l Consultants register for this webinar 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 43337 Livermore Common, Fremont, CA 94539, USA 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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