{"id":45017,"date":"2022-06-13T18:01:44","date_gmt":"2022-06-13T16:01:44","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\/"},"modified":"2022-06-13T18:01:44","modified_gmt":"2022-06-13T16:01:44","slug":"medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\/","title":{"rendered":"Medical Device Software and Cybersecurity Courses &#8211; 5 Webinar Bundle &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5598593\/medical-device-software-and-cybersecurity-courses?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=6zwcw6&amp;utm_campaign=1712919+-+Medical+Device+Software+and+Cybersecurity+Courses+-+5+Webinar+Bundle&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Medical Device Software and Cybersecurity Courses &#8211; 5 Webinar Pack&#8221;<\/a> webinar has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220613005687\/en\/1484737\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220613005687\/en\/1484737\/21\/logo.jpg\"><\/a><\/p>\n<p>\n<strong>This exclusive Pack contains 5 courses:<\/strong>\n<\/p>\n<p>\n1. IEC 62304 for Medical Device Software\n<\/p>\n<p>\n2. Drafting a Software V&amp;V Documentation Package and Protocol\n<\/p>\n<p>\n3. Validation of Non-Product Software\n<\/p>\n<p>\n4. IEC 62304 and Demystifying Software Validation using the Principles of LDLC\n<\/p>\n<p>\n5. Medical Device Cybersecurity and FDA Compliance\n<\/p>\n<p>\n<strong>Total Duration: <\/strong>10 Hours\n<\/p>\n<p>\nMedical device software can make or break a device. Badly developed, non-compliant software can compromise a device&#8217;s safety and reliability. The goal is that upon completion of this pack of courses, you should understand how to create and maintain safe software for medical devices throughout their life cycles. In addition to this, you should also understand how IEC 62304 interlinks with other standards such as ISO 14971 and ISO 13485.\n<\/p>\n<p>\nThe courses include IEC 62304 requirements and explains risk-based approach for Verification and Validation using protocols and GAMP. What if your software is not a product; how would you validate it? Well, this pack has answers to that.\n<\/p>\n<p>\nNext, it takes you through a process of software validation giving you a complete overview of the imminent changes and their implications, using an innovative approach yet is based upon solid principles and proven practices. And finally, and importantly, the cyber-attacks threaten medical devices and how the industry is currently responding to them. You will learn the many ways of preventing and mitigating the cybersecurity risk, and about the industry&#8217;s best practices that can help your company do the same.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nSenior management, Project Leaders, Internal\/External consultants\n<\/li>\n<li>\nMid-level Management and Supervisory Personnel\n<\/li>\n<li>\nRegulatory Affairs Departments\n<\/li>\n<li>\nQuality Systems\/QAE Departments\n<\/li>\n<li>\nR&amp;D Departments\n<\/li>\n<li>\nEngineering Departments\n<\/li>\n<li>\nNew Product Development Departments\n<\/li>\n<li>\nValidation Technicians\n<\/li>\n<li>\nIT Departments\n<\/li>\n<li>\nMedical Device, Equipment\/Process SW Programmers\n<\/li>\n<\/ul>\n<p>\n<strong>Agenda<\/strong>\n<\/p>\n<p>\n<strong>TOPIC 1: IEC 62304 for Medical Device Software<\/strong>\n<\/p>\n<p>\n<strong>Speaker: <\/strong>Nancy Knettell\n<\/p>\n<p>\n<strong>Duration:<\/strong> 60 Minutes\n<\/p>\n<ul>\n<li>\nWhy is having an IEC62304 Compliant Software Quality System important to both developing your software for 510K approval and how you can be putting your company at risk post-approval if you do not have a compliant system in place.\n<\/li>\n<li>\nWhat is IEC62304 and how does it differ from other Compliance Standards such as ISO13485\n<\/li>\n<li>\nWhat are the elements that constitute an IEC62304 Compliant System?\n<\/li>\n<li>\nBenefits of developing to an IEC62304 standard\n<\/li>\n<li>\nWhat are the components of the Software Lifecycle\n<\/li>\n<li>\nWhat are the major Software Work Products developed to the standard?\n<\/li>\n<li>\nHow it fits in with a Company&#8217;s Standard Quality Process\n<\/li>\n<li>\nOne of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed\n<\/li>\n<li>\nWhat are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place\n<\/li>\n<li>\nUnderstand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices\n<\/li>\n<li>\nWhat constitutes compliance with the Standard\n<\/li>\n<li>\nWhat areas does the Guidance Address\n<\/li>\n<li>\nWhat are the legal consequences for the company with the submittal if the company does not adhere to the Guidance\n<\/li>\n<\/ul>\n<p>\n<strong>TOPIC 2: Drafting a Software V&amp;V Documentation Package and Protocol<\/strong>\n<\/p>\n<p>\n<strong>Speaker: <\/strong>John E. Lincoln\n<\/p>\n<p>\n<strong>Duration:<\/strong> 90 Minutes\n<\/p>\n<ul>\n<li>\nVerification or Validation\n<\/li>\n<li>\nCurrent Regulatory Expectations and &#8220;Hot Buttons&#8221;\n<\/li>\n<li>\nThe Project Validation Plan\n<\/li>\n<li>\nProduct and Process \/ Equipment Software V&amp;V\n<\/li>\n<li>\nWhen and How to Use DQ, IQ, OQ, PQ\n<\/li>\n<li>\nGAMP Considerations\n<\/li>\n<li>\nThe FDA&#8217;s 11 Key Elements\n<\/li>\n<li>\nWhite Box and &#8220;Black Box&#8221; Validations\n<\/li>\n<\/ul>\n<p>\n<strong>TOPIC 3: Validation of Non-Product Software<\/strong>\n<\/p>\n<p>\n<strong>Speaker:<\/strong> Thomas Bento\n<\/p>\n<p>\n<strong>Duration: <\/strong>60 Minutes\n<\/p>\n<ul>\n<li>\nSoftware used as part of the manufacturing process (including software embedded in machine tools, statistical process control software, programmable logic controllers [PLCs], and software in automated inspection or test systems).\n<\/li>\n<li>\nSoftware used in process validation (such as statistical calculation software, spreadsheets, etc.).\n<\/li>\n<li>\nSoftware used in design and development processes (such as CAD software, CAM software, software development tools, software test tools, compilers, editors, code generators, etc.).\n<\/li>\n<li>\nSoftware used to automate part of the quality process (such as complaint-handling systems, lot-tracking systems, training-database systems, etc.).\n<\/li>\n<li>\nSoftware used to create, transmit, modify, or store electronic records that are required by regulation.\n<\/li>\n<li>\nSoftware used to implement electronic signatures for documents required by regulation.\n<\/li>\n<\/ul>\n<p>\n<strong>TOPIC 4: IEC 62304 and Demystifying Software Validation using the Principles of LDLC<\/strong>\n<\/p>\n<p>\n<strong>Speaker:<\/strong> Jose Mora\n<\/p>\n<p>\n<strong>Duration:<\/strong> 180 Minutes\n<\/p>\n<p>\n<strong>Lecture 1:<\/strong>\n<\/p>\n<ul>\n<li>\nWhy is having an IEC62304 Compliant Software Quality System important to both developing your software for 510K approval and how you can be putting your company at risk post-approval if you do not have a compliant system in place\n<\/li>\n<li>\nWhat is IEC62304 and how does it differ from other Compliance Standards such as ISO13485\n<\/li>\n<li>\nWhat are the elements that constitute an IEC62304 Compliant System?\n<\/li>\n<li>\nBenefits of developing to an IEC62304 standard\n<\/li>\n<li>\nWhat are the components of the Software Lifecycle\n<\/li>\n<li>\nWhat are the major Software Work Products developed to the standard?\n<\/li>\n<li>\nHow it fits in with a Company&#8217;s Standard Quality Process\n<\/li>\n<li>\nWhat are the legal consequences for the company with the submittal if the company does not adhere to the Guidance\n<\/li>\n<\/ul>\n<p>\n<strong>Lecture 2:<\/strong>\n<\/p>\n<ul>\n<li>\nOne of the most common reasons that a Software Enabled Medical Device is denied a 510K is because the Guidance has not been followed\n<\/li>\n<li>\nWhat are the potential audit consequences if the Company does not have an IEC62304 Compliance Quality System in place\n<\/li>\n<li>\nUnderstand the regulatory need for IEC 62304 Guidance as it relates to submitting a 510K for Software Enabled Medical Devices\n<\/li>\n<li>\nWhat constitutes compliance with the Standard\n<\/li>\n<li>\nWhat areas does the Guidance Address\n<\/li>\n<li>\nWhat are the legal consequences for the company with the submittal if the company does not adhere to the Guidance\n<\/li>\n<\/ul>\n<p>\n<strong>Lecture 3:<\/strong>\n<\/p>\n<ul>\n<li>\nReview of Lean Documents and Lean Configuration concepts\n<\/li>\n<li>\nSoftware Validation:\n<\/li>\n<li>\nSoftware configuration\n<\/li>\n<li>\nGeneral setup\n<\/li>\n<li>\nOrganization\n<\/li>\n<li>\nUser Management\n<\/li>\n<li>\nRights Groups, Roles, and Actors\n<\/li>\n<li>\nProducts\n<\/li>\n<li>\nProcesses\n<\/li>\n<li>\nFailure Modes, Process Signals, Tasks\n<\/li>\n<li>\nScreens, menus, and modules\n<\/li>\n<li>\nProcess validation steps\n<\/li>\n<li>\nBringing them all together\n<\/li>\n<\/ul>\n<p>\n<strong>TOPIC 5: Medical Device Cybersecurity and FDA Compliance<\/strong>\n<\/p>\n<p>\n<strong>Speaker: <\/strong>Carolyn Troiano\n<\/p>\n<p>\n<strong>Duration:<\/strong> 210 Minutes\n<\/p>\n<p>\n<strong>Session 1:<\/strong>\n<\/p>\n<ul>\n<li>\nCybersecurity and guidance on device software\n<\/li>\n<\/ul>\n<p>\n<strong>Session 2:<\/strong>\n<\/p>\n<ul>\n<li>\nMost common problems faced by the industry in terms of medical device security, efficacy, and safety\n<\/li>\n<\/ul>\n<p>\n<strong>Session 3:<\/strong>\n<\/p>\n<ul>\n<li>\nBest practices and industry standards to meet the challenges of cybersecurity and other threats to devices and software\n<\/li>\n<\/ul>\n<p>\nFor more information about this webinar visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5598593\/medical-device-software-and-cybersecurity-courses?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=6zwcw6&amp;utm_campaign=1712919+-+Medical+Device+Software+and+Cybersecurity+Courses+-+5+Webinar+Bundle&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/n9c22s<\/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=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;:&#x70;r&#x65;s&#115;&#x40;&#114;&#x65;&#115;&#x65;&#97;&#x72;c&#x68;a&#x6e;d&#109;&#x61;&#114;&#x6b;&#101;&#x74;&#115;&#x2e;c&#x6f;m\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#114;e&#x73;&#115;&#64;&#x72;&#101;s&#x65;&#97;r&#x63;&#104;a&#x6e;&#100;m&#x61;&#114;k&#x65;&#116;s&#x2e;&#99;o&#x6d;<\/a><\/p>\n<p>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 Device Software and Cybersecurity Courses &#8211; 5 Webinar Pack&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. This exclusive Pack contains 5 courses: 1. IEC 62304 for Medical Device Software 2. Drafting a Software V&amp;V Documentation Package and Protocol 3. Validation of Non-Product Software 4. IEC 62304 and Demystifying Software Validation using the &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-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-45017","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 Device Software and Cybersecurity Courses - 5 Webinar Bundle - 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-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Software and Cybersecurity Courses - 5 Webinar Bundle - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Medical Device Software and Cybersecurity Courses &#8211; 5 Webinar Pack&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. This exclusive Pack contains 5 courses: 1. IEC 62304 for Medical Device Software 2. Drafting a Software V&amp;V Documentation Package and Protocol 3. Validation of Non-Product Software 4. IEC 62304 and Demystifying Software Validation using the ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-13T16:01:44+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20220613005687\/en\/1484737\/21\/logo.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/medical-device-software-and-cybersecurity-courses-5-webinar-bundle-researchandmarkets-com\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"Medical Device Software and Cybersecurity Courses &#8211; 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5 Webinar Pack&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. This exclusive Pack contains 5 courses: 1. IEC 62304 for Medical Device Software 2. Drafting a Software V&amp;V Documentation Package and Protocol 3. Validation of Non-Product Software 4. IEC 62304 and Demystifying Software Validation using the ... 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