{"id":55905,"date":"2024-06-10T15:36:18","date_gmt":"2024-06-10T15:36:18","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/06\/10\/quality-and-compliance-management-course-for-virtual-companies-online-july-11-12-2024-researchandmarkets-com\/"},"modified":"2024-06-10T15:36:18","modified_gmt":"2024-06-10T15:36:18","slug":"quality-and-compliance-management-course-for-virtual-companies-online-july-11-12-2024-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/quality-and-compliance-management-course-for-virtual-companies-online-july-11-12-2024-researchandmarkets-com\/","title":{"rendered":"Quality and Compliance Management Course for Virtual Companies (ONLINE: July 11-12, 2024) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5853883\/quality-compliance-management-virtual-companies?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=pgbqns&amp;utm_campaign=1968017+-+Quality+and+Compliance+Management+Course+for+Virtual+Companies+(ONLINE%3A+July+11-12%2C+2024)&amp;utm_exec=chdomspi\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Quality and Compliance Management for Virtual Companies&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20240610154122\/en\/2155164\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20240610154122\/en\/2155164\/22\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20240610154122\/en\/2155164\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20240610154122\/en\/2155164\/21\/logo.jpg\"><\/a><\/p>\n<p>\nRunning a pharmaceutical company is not easy, especially if you have an outsourcing model. There are multiple crucial steps for which you need to depend on contract manufacturers and researchers. Additionally, due to the majority of outsourced products, the team may lack quality assurance and GMP compliance.<\/p>\n<p>\nTo evolve from your current expertise and enter Phase 2 and 3 of clinical trials, it is essential to have a strong hold on pharmaceutical GMP compliance. This seminar consists of two days of rigorous training for professionals from virtual companies. You will learn all major requirements and expectations that are applicable to you and your team.<\/p>\n<p>\n<strong>Course Overview<\/strong><\/p>\n<p>\nAs a virtual company also, it is your responsibility to adhere to the guidelines laid by FDA, EMA, and Health Canada. However, the first step is to diagnose your company&#8217;s requirements and pick industry best practices to be followed.<\/p>\n<p>\nThe pharma GMP compliance for virtual companies is not just limited to your own practices. It is essential to choose the right contractors after proper qualification testing and monitoring. In addition to strengthening your brand or business&#8217;s value, this training will allow you to grow and expand in the coming months.<\/p>\n<p>\n<strong>Some of the benefits of knowing the prerequisites of GMP audits are:<\/strong><\/p>\n<ul>\n<li>\nFunction beyond the outsourcing model<\/li>\n<li>\nChoose the right contractors and C-level executives for your business.<\/li>\n<li>\nFormulate a top-notch quality agreement.<\/li>\n<li>\nAlign your internal operations with that of the outsourced.<\/li>\n<li>\nRelease your product successfully for clinical and market use<\/li>\n<li>\nManage the inspections by responding with the required documents.<\/li>\n<\/ul>\n<p>\n<strong>8.0 RAC CREDITS<\/strong><\/p>\n<p>\nRAPS &#8211; This course has been pre-approved by RAPS as eligible for up to 8 credits towards a participant&#8217;s RAC recertification upon full completion.<\/p>\n<p>\n<strong>Who Should Attend:<\/strong><\/p>\n<p>\nThis seminar on GMP compliance is typically designed for virtual companies that are going to welcome the commercial growth phase in the coming time. Hence, every professional associated with operations and auditing will benefit from the seminar.<\/p>\n<ul>\n<li>\nQuality Managers and Analysts: Gain ideas about managing product quality when the company transitions from an outsourcing model.<\/li>\n<li>\nClinical Operations: Understand the requirements for a clinical product&#8217;s approval in the market.<\/li>\n<li>\nDocument Control Specialists: Learn the requirements of the FDA in terms of documents so that you can present them during the inspection.<\/li>\n<li>\nRegulatory Professionals: Supervise the overall function and perform internal audits effectively.<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong><\/p>\n<p>\n<strong>DAY 01 (12:00 PM &#8211; 04:00 PM)<\/strong><\/p>\n<ul>\n<li>\nIntroductions and participant expectations for the program<\/li>\n<li>\nFundamentals of Good Manufacturing Practice<\/li>\n<li>\nWhat is GMP?<\/li>\n<li>\nPurpose of GMP<\/li>\n<li>\nBasis in law: US, Europe, Canada<\/li>\n<li>\nElements that apply to all virtual companies<\/li>\n<li>\nElements that depend on how operations are conducted: How to tell what applies to your company<\/li>\n<\/ul>\n<p>\n<strong>Data Integrity: What it is and why it is important to GMP<\/strong><\/p>\n<ul>\n<li>\nFundamentals of Good Clinical Practice (GCP)<\/li>\n<li>\nWhat is GCP?<\/li>\n<li>\nPurpose of GCP<\/li>\n<li>\nBasis in law: US, Europe, Canada<\/li>\n<li>\nElements that apply to all virtual companies<\/li>\n<li>\nElements that depend on how operations are conducted: How to tell what applies to your company<\/li>\n<\/ul>\n<p>\n<strong>Regulatory and business risks: The case for compliance<\/strong><\/p>\n<ul>\n<li>\nVirtual company organizational structure and responsibility for QA\/GMP\/GCP<\/li>\n<li>\nVirtual company quality system structure and management<\/li>\n<li>\nPolicies, procedures, documentation management<\/li>\n<li>\nMetrics and management review considerations<\/li>\n<\/ul>\n<p>\n<strong>Selection, qualification, and monitoring of contractors<\/strong><\/p>\n<ul>\n<li>\nInitial due diligence &#8211; public information sources to gage compliance<\/li>\n<li>\nQualification of vendors<\/li>\n<li>\nQuality agreements &#8211; determining and documenting responsibilities for GMP<\/li>\n<li>\nVendor audit program<\/li>\n<li>\nDay One Q&amp;A and recap of progress meeting stated course expectations<\/li>\n<\/ul>\n<p>\n<strong>DAY 02 (12:00 PM &#8211; 04:00 PM)<\/strong><\/p>\n<ul>\n<li>\nRegulatory Inspections<\/li>\n<li>\nPurpose of an inspection<\/li>\n<li>\nReasons for inspections<\/li>\n<li>\nInspections at virtual company headquarters locations &#8211; purpose and scope<\/li>\n<li>\nInspections at CMOs and Contract Labs<\/li>\n<li>\nGMP inspections versus Preapproval inspections &#8211; FDA<\/li>\n<li>\nGCP inspections of sponsors of clinical trials<\/li>\n<li>\nEMA inspections &#8211; contrast with FDA<\/li>\n<li>\nHealth Canada inspections<\/li>\n<\/ul>\n<p>\n<strong>Logistics for managing inspections at your location<\/strong><\/p>\n<ul>\n<li>\nInformation sources about inspections on agency websites: What you need and how to find it easily<\/li>\n<li>\nPreparation for inspections<\/li>\n<li>\nOverall process &#8211; ready room support<\/li>\n<li>\nReceiving and hosting the inspectors<\/li>\n<li>\nProviding documents<\/li>\n<li>\nAnswering questions<\/li>\n<li>\nInterpersonal dos and don&#8217;ts for interacting with inspectors<\/li>\n<li>\nManaging the exit discussion at the conclusion of the inspection<\/li>\n<\/ul>\n<p>\n<strong>Inspections at your contract organizations<\/strong><\/p>\n<ul>\n<li>\nMake sure your CMO and contract lab are &#8220;PAI ready&#8221;<\/li>\n<li>\nTraining employees to assure inspection readiness &#8211; pitfalls to make sure you avoid<\/li>\n<li>\nConducting mock inspections effectively<\/li>\n<\/ul>\n<p>\n<strong>Post-inspection communications with the inspecting agency<\/strong><\/p>\n<ul>\n<li>\nHow to write an effective response<\/li>\n<li>\nCommon mistakes to avoid<\/li>\n<li>\nFollowing up to ensure the response is satisfactory<\/li>\n<li>\nWhen to request a meeting, and if granted, how best to handle it<\/li>\n<\/ul>\n<p>\n<strong>Enforcement considerations<\/strong><\/p>\n<ul>\n<li>\nFDA enforcement process &#8211; domestic and ex-US<\/li>\n<li>\nEMA enforcement<\/li>\n<li>\nHealth Canada<\/li>\n<li>\nFinal Q&amp;A, discussion, and conclusion<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong><\/p>\n<p>\nKelly Thomas<br \/>\n<br \/>Vice President<br \/>\n<br \/>Stallergenes Greer<\/p>\n<p>\nMs. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process\/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment\/automated processes and cleaning validation.<\/p>\n<p>\nUtilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5853883\/quality-compliance-management-virtual-companies?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=pgbqns&amp;utm_campaign=1968017+-+Quality+and+Compliance+Management+Course+for+Virtual+Companies+(ONLINE%3A+July+11-12%2C+2024)&amp;utm_exec=chdomspi\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/you1fz<\/a><\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong><\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.<\/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@researchandmarkets.com\" rel=\"nofollow noopener\" shape=\"rect\">press@researchandmarkets.com<\/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<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Quality and Compliance Management for Virtual Companies&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. Running a pharmaceutical company is not easy, especially if you have an outsourcing model. There are multiple crucial steps for which you need to depend on contract manufacturers and researchers. Additionally, due to the majority of outsourced products, the [&#8230;]\n","protected":false},"author":1,"featured_media":55906,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[],"class_list":["post-55905","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-economy"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality and Compliance Management Course for Virtual Companies (ONLINE: July 11-12, 2024) - ResearchAndMarkets.com - Biz and Live in Saigon<\/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:\/\/english.saigonbiz.com\/vn\/quality-and-compliance-management-course-for-virtual-companies-online-july-11-12-2024-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality and Compliance Management Course for Virtual Companies (ONLINE: July 11-12, 2024) - ResearchAndMarkets.com\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Quality and Compliance Management for Virtual Companies&#8221; 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