{"id":45593,"date":"2022-06-28T16:01:58","date_gmt":"2022-06-28T14:01:58","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/medical-devices-post-market-surveillance-online-course-product-complaints-management-medical-device-reporting-vigilance-reporting-product-recalls-july-29-2022-researchandmarkets-com\/"},"modified":"2022-06-28T16:01:58","modified_gmt":"2022-06-28T14:01:58","slug":"medical-devices-post-market-surveillance-online-course-product-complaints-management-medical-device-reporting-vigilance-reporting-product-recalls-july-29-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/medical-devices-post-market-surveillance-online-course-product-complaints-management-medical-device-reporting-vigilance-reporting-product-recalls-july-29-2022-researchandmarkets-com\/","title":{"rendered":"Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5610476\/medical-devices-post-market-surveillance?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=c7w3sb&amp;utm_campaign=1719520+-+Medical+Devices+Post+Market+Surveillance+Online+Course%3A+Product+Complaints+Management%2C+Medical+Device+Reporting%2C+Vigilance+Reporting%2C+Product+Recalls+(July+29%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Medical Devices &#8211; Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220628005858\/en\/1499343\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220628005858\/en\/1499343\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis course will provide practical guidance and real-life examples that will help you develop and\/or optimize your company&#8217;s post market surveillance system. It is essential to have an effective, efficient and robust medical device post market surveillance system.\n<\/p>\n<p>\nThese are key elements for early identification and rapid response to problems with marketed products. In addition to the obvious need to comply with regulatory requirements, it is also vital from a business standpoint to understand the importance of complaint management, MDR&#8217;s, vigilance reporting, and product recalls. A robust post market surveillance system helps to prevent unnecessary patient injuries, reduces the chances for financial loss, and it could result in improved products.\n<\/p>\n<p>\nComplaint management, MDRs, EU vigilance reporting, and product recalls are top priorities in FDA and notified body inspections. For example, 40% of all FDA Warning Letters are related to issues involving the complaint management system. Additionally, four recent Warning Letters issued by the FDA involved issues related to MDRs.\n<\/p>\n<p>\n<strong>This interactive seminar will focus on:<\/strong>\n<\/p>\n<ul>\n<li>\nComplaint Management\n<\/li>\n<li>\nMedical Device Reporting (MDR)\n<\/li>\n<li>\nEU Vigilance Reporting\n<\/li>\n<li>\nProduct Recalls\n<\/li>\n<\/ul>\n<p>\n<strong>Learning Objectives :<\/strong>\n<\/p>\n<p>\nKey goal of this course is to understand:\n<\/p>\n<ul>\n<li>\nLegal authorities (statutes and regulations) and definitions applicable to key elements of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)\n<\/li>\n<li>\nRegulatory and compliance requirements related to each element of Post Market Surveillance (Complaint Management, MDRs, Vigilance and Product Recalls)\n<\/li>\n<li>\nImplementing applicable processes and procedures for Complaint Management, MDRs, Vigilance and Product Recalls\n<\/li>\n<li>\nManagement review and dissemination of Post Market Surveillance information\n<\/li>\n<li>\nWhat to do when a complaint is received:<\/p>\n<ul>\n<li>\nWhat\/how\/when to investigate a complaint\n<\/li>\n<li>\nContents of records of complaint investigation\n<\/li>\n<li>\nHow to adjudicate the complaint\n<\/li>\n<li>\nImplementing interactive systems between complaint handling, medical device reporting, and CAPA\n<\/li>\n<\/ul>\n<\/li>\n<li>\nSubmission of MDR&#8217;s to the FDA:<\/p>\n<ul>\n<li>\nWhat\/how\/when to submit an MDR\n<\/li>\n<li>\nContents of the reporting form\n<\/li>\n<li>\nUtilizing MDR information as qualitative data\n<\/li>\n<\/ul>\n<\/li>\n<li>\nSubmission of Vigilance Reports to EU Competent Authorities:<\/p>\n<ul>\n<li>\nWhat\/how\/when to submit a Vigilance Report\n<\/li>\n<li>\nContents of the reporting form\n<\/li>\n<\/ul>\n<\/li>\n<li>\nWhat to do when a medical device needs to be recalled:<\/p>\n<ul>\n<li>\nWhat\/how\/when to initiate a medical device product recall\n<\/li>\n<li>\nContents of the recall reports and records\n<\/li>\n<li>\nRecall execution and closure\n<\/li>\n<\/ul>\n<\/li>\n<li>\nTo discussion of key case studies and how to prevent compliance issues related to Complaint Management, MDR, Vigilance reporting and medical device product recalls\n<\/li>\n<li>\nTo review the key concepts and implementation steps for an effective Post Market Surveillance system\n<\/li>\n<\/ul>\n<p>\n<em><strong>Time: 9:00 AM &#8211; 4:30 PM PDT<\/strong><\/em>\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\n<strong>Anyone that participates in product complaint management, medical device reporting, vigilance reporting, and\/or product recalls:<\/strong>\n<\/p>\n<ul>\n<li>\nRegulatory Affairs Personnel\n<\/li>\n<li>\nQuality managers and those working in sales or marketing\n<\/li>\n<li>\nLegal Personnel\n<\/li>\n<li>\nCompliance Professionals\n<\/li>\n<li>\nClinical affairs specialists and those handling complaints\n<\/li>\n<li>\nMedical Affair Professionals\n<\/li>\n<li>\nDesign Control Managers\n<\/li>\n<li>\nRisk Managers\n<\/li>\n<\/ul>\n<p>\n<strong>July 29, 2022 (9:00 AM to 4:30 PM PDT)<\/strong>\n<\/p>\n<p>\n<strong>Registration Process: 8:30 AM &#8211; 9:00 AM<\/strong>\n<\/p>\n<p>\n<strong>9.00 &#8211; 10.30: The Basics of Quality System Regulations and Post Market Surveillance Activities<\/strong>\n<\/p>\n<ul>\n<li>\nRegulatory Overview\n<\/li>\n<li>\nGeneral Provisions of the Regulation\n<\/li>\n<li>\nQuality Management\n<\/li>\n<li>\nMonitoring and Feedback\n<\/li>\n<li>\nPurpose of Risk Management\n<\/li>\n<\/ul>\n<p>\n<strong>10.30 &#8211; 11.30: Product Complaint Management<\/strong>\n<\/p>\n<ul>\n<li>\nWhat is a complaint?\n<\/li>\n<li>\nWhy do we collect product complaints\n<\/li>\n<li>\nManagement of product complaints\n<\/li>\n<li>\nDeveloping a complaint management procedure\n<\/li>\n<li>\nAnalyzing product complaint data\n<\/li>\n<li>\nEffective utilization of product complaint data\n<\/li>\n<\/ul>\n<p>\n<strong>11.30 &#8211; 12.30: Medical Device Reporting<\/strong>\n<\/p>\n<ul>\n<li>\nReview of the MDR regulation\n<\/li>\n<li>\nSources of MDRs\n<\/li>\n<li>\nSubmission MDRs (initial and follow up)\n<\/li>\n<li>\nEffective utilization of MDR data\n<\/li>\n<\/ul>\n<p>\n<strong>12.30 &#8211; 01.30: Lunch<\/strong>\n<\/p>\n<p>\n<strong>01.30 &#8211; 02.45: Medical Devices European Vigilance Reporting<\/strong>\n<\/p>\n<ul>\n<li>\nReview of the reporting requirements\n<\/li>\n<li>\nSubmission of Vigilance reporting forms\n<\/li>\n<li>\nProper completion of the Vigilance reporting form\n<\/li>\n<li>\nDealing with Notified Body and Competent Authorities\n<\/li>\n<\/ul>\n<p>\n<strong>02.45 &#8211; 04.00: Medical Device Recalls<\/strong>\n<\/p>\n<ul>\n<li>\nReview of the regulation\n<\/li>\n<li>\nWhat is a recall?\n<\/li>\n<li>\nOther action types\n<\/li>\n<li>\nUtilizing internal resources\n<\/li>\n<li>\nRecall records\n<\/li>\n<li>\nCoordinating with regulatory agencies\n<\/li>\n<li>\nClosing out a product recall\n<\/li>\n<\/ul>\n<p>\n<strong>04.00 &#8211; 04.30: Questions and Answers<\/strong>\n<\/p>\n<p>\n<strong>Speakers:<\/strong>\n<\/p>\n<p>\nProf. Dr. h.c. Frank Stein\n<\/p>\n<p>\nSenior Medical Device Expert\n<\/p>\n<p>\nNemius Consulting GmbH\n<\/p>\n<p>\nDr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.\n<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5610476\/medical-devices-post-market-surveillance?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=c7w3sb&amp;utm_campaign=1719520+-+Medical+Devices+Post+Market+Surveillance+Online+Course%3A+Product+Complaints+Management%2C+Medical+Device+Reporting%2C+Vigilance+Reporting%2C+Product+Recalls+(July+29%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/o9rqes<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"mailto:press&#64;researchand&#109;&#97;&#114;&#107;&#101;&#116;&#115;&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;e&#115;&#x73;&#64;&#x72;&#x65;&#115;&#x65;a&#114;&#x63;h&#97;&#x6e;&#100;&#x6d;a&#114;&#x6b;e&#116;&#x73;&#46;&#x63;&#x6f;&#109;<\/a><br \/>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Medical Devices &#8211; Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. This course will provide practical guidance and real-life examples that will help you develop and\/or optimize your company&#8217;s post market surveillance system. It is essential to have an effective, efficient &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/medical-devices-post-market-surveillance-online-course-product-complaints-management-medical-device-reporting-vigilance-reporting-product-recalls-july-29-2022-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45593","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022) - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/medical-devices-post-market-surveillance-online-course-product-complaints-management-medical-device-reporting-vigilance-reporting-product-recalls-july-29-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Devices Post Market Surveillance Online Course: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls (July 29, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Medical Devices &#8211; Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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This course will provide practical guidance and real-life examples that will help you develop and\/or optimize your company&#8217;s post market surveillance system. It is essential to have an effective, efficient ... 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