Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

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Medical Device Complaints Handling Strategies for Managing Your Biggest Compliance Challenge

This Medical device complaints handling webinar will discuss the best practices of complaint handling and how to include it in your CAPA program and how to apply risk management to the complaint handling system.Why You Should Attend: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.Who Will Benefit:This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:Regulatory managementQA managementCustomer Service personnelSales personnelConsultantsQuality system auditorsInstructor Profile:Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.Note:Use coupon code NB5SQH8N and get 10% off on registration.For Registration:http://www.complianceonline.com/medical-device-complaints-handling-strategies-for-compliance-webinar-training-701788-prdw?channel=scientistsolutions