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Overview: This presentation will step through the FDA regulations relating to post-market product problems, and give examples of how FDA currently interprets these regulations. Following this presentation, you should be able to decide whether your customer complaint requires not only investigation, but reporting to FDA, and in what format the report should be made, and to which section of the Agency. Why Should You Attend : Many device warning letters contain the complaint that the company has failed to adequately develop and maintain their system for dealing with product problems in the field, and that their response to the 483 pointing out this deficiency was inadequate, usually because it was not accompanied by revised documents, and evidence that personnel were adequately trained on the revised system, and evidence that the revised system was in fact working effectively. One major component of the description usually found lacking is the determination of when and how to notify FDA of the problem and how the company is dealing with it. Areas Covered in the Session QSR Requirements for Complaint Handling 21 CFR 820.198 Medical Device Reporting 21 CFR Part 803 Reports of Corrections and Removals, 21 CFR Part 806 HCT/P that are devices Combination Products Electronic Products When MDR, When electronic product reporting Repurchase, Repairs, Replacement Who Will Benefit: QA specialist Complaint Coordinator Regulatory Specialist QA manager QA Trainer All above in Medical Device companies Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1ifblmd
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