{"id":60989,"date":"2025-03-26T19:03:33","date_gmt":"2025-03-26T18:03:33","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-and-document-management-training-course-a-key-focus-of-regulatory-inspections-with-both-eu-and-fda-inspectors-online-event-april-7-2025-on-demand-researchandmarkets-com\/"},"modified":"2025-03-26T19:03:33","modified_gmt":"2025-03-26T18:03:33","slug":"pharma-data-integrity-and-document-management-training-course-a-key-focus-of-regulatory-inspections-with-both-eu-and-fda-inspectors-online-event-april-7-2025-on-demand-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-and-document-management-training-course-a-key-focus-of-regulatory-inspections-with-both-eu-and-fda-inspectors-online-event-april-7-2025-on-demand-researchandmarkets-com\/","title":{"rendered":"Pharma Data Integrity and Document Management Training Course: A Key Focus of Regulatory Inspections with Both EU and FDA Inspectors (ONLINE EVENT: April 7, 2025 &amp; ON-DEMAND) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6026736\/data-integrity-document-management-training-course?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=5vvkwk&amp;utm_campaign=2046874+-+Pharma+Data+Integrity+and+Document+Management+Training+Course%3A+A+Key+Focus+of+Regulatory+Inspections+with+Both+EU+and+FDA+Inspectors+(ONLINE+EVENT%3A+April+7%2C+2025+%26+ON-DEMAND)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">&#8220;Data Integrity and Document Management Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20250326375939\/en\/2421002\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250326375939\/en\/2421002\/22\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20250326375939\/en\/2421002\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20250326375939\/en\/2421002\/21\/logo.jpg\"><\/a><\/p>\n<p>\nDocument management and data integrity are a key focus of regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area.\n<\/p>\n<p>\nEnsuring data integrity is an important component of the pharma industry&#8217;s responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, including warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines.\n<\/p>\n<p>\nThis concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. The programme will include discussion of the latest MHRA data integrity guide and EMA TMF guideline that should be considered by organisations involved in any aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP). You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.\n<\/p>\n<p>\n<strong>Benefits of attending:<\/strong>\n<\/p>\n<ul>\n<li>\nUnderstand the importance of data integrity and good document practice\n<\/li>\n<li>\nEnsure you are compliant with the new EU trial master file (TMF) guideline\n<\/li>\n<li>\nBe aware of key regulations and guidelines\n<\/li>\n<li>\nDiscuss QMS considerations for data integrity and document management\n<\/li>\n<li>\nReview document management and data integrity inspections to facilitate regulatory compliance\n<\/li>\n<li>\nConsider the requirements for document management and data integrity governance to prevent data integrity breaches\n<\/li>\n<li>\nThis course is part of the GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.\n<\/li>\n<\/ul>\n<p>\n<strong>Certification:<\/strong>\n<\/p>\n<ul>\n<li>\nCPD: 6 hours for your records\n<\/li>\n<li>\nCertificate of completion\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<p>\nThis course is designed for managers and staff from all GxP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and\/or reporting of data to ensure data integrity, in particular those working in:\n<\/p>\n<ul>\n<li>\nClinical trials\n<\/li>\n<li>\nManufacturing\n<\/li>\n<li>\nQuality assurance\/quality control\n<\/li>\n<li>\nCompliance\n<\/li>\n<li>\nPharmacovigilance\n<\/li>\n<\/ul>\n<p>\nQA personnel from CROs\/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme.\n<\/p>\n<p>\n<strong>Agenda:<\/strong>\n<\/p>\n<p>\n<strong>Principles of data integrity and good documentation practice<\/strong>\n<\/p>\n<ul>\n<li>\nWhat is data integrity?\n<\/li>\n<li>\nWhy is data integrity important?\n<\/li>\n<li>\nALCOA principles\n<\/li>\n<li>\nGood documentation practice including paper and electronic records\n<\/li>\n<\/ul>\n<p>\n<strong>Data integrity regulations and guidelines<\/strong>\n<\/p>\n<ul>\n<li>\nMHRA\/WHO\/FDA\/EMA\/PICS\/ICH GCP R2 data integrity guidelines\n<\/li>\n<li>\nGroup review and discussion of some key regulated documents including the latest MHRA data integrity guide\n<\/li>\n<\/ul>\n<p>\n<strong>Document management and data integrity inspection findings<\/strong>\n<\/p>\n<ul>\n<li>\nMHRA, EMA findings, EU non-compliance reports\n<\/li>\n<li>\nFDA findings\n<\/li>\n<li>\nGroup discussion on inspection findings\n<\/li>\n<\/ul>\n<p>\n<strong>QMS considerations for Data integrity and documentation<\/strong>\n<\/p>\n<ul>\n<li>\nWhat are the elements of QMS for data integrity?\n<\/li>\n<li>\nRisk management considerations\n<\/li>\n<li>\nData governance\n<\/li>\n<li>\nDiscussion of participants experience and best practice for QMS and data governance\n<\/li>\n<\/ul>\n<p>\n<strong>Data integrity for computer systems<\/strong>\n<\/p>\n<ul>\n<li>\nComputer system validation considerations\n<\/li>\n<li>\nWhat is expected for compliance for GxP systems?\n<\/li>\n<\/ul>\n<p>\n<strong>Discussion of document and data integrity issues<\/strong>\n<\/p>\n<ul>\n<li>\nData integrity and digital signatures\n<\/li>\n<li>\nCertified copies\/true copies\n<\/li>\n<li>\nManaging and preventing data integrity breaches\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong>\n<\/p>\n<p>\nLaura Brown<br \/>\n<br \/>Pharmaceutical QA and Training Consultant<br \/>\n<br \/>University of Cardiff\n<\/p>\n<p>\nDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years&#8217; experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including &#8220;The Planning of International Drug Development&#8221;, in the Clinical Research Manual, Euromed and the &#8220;Impact of Brexit&#8221;, RQA Journal 2017.\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6026736\/data-integrity-document-management-training-course?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=5vvkwk&amp;utm_campaign=2046874+-+Pharma+Data+Integrity+and+Document+Management+Training+Course%3A+A+Key+Focus+of+Regulatory+Inspections+with+Both+EU+and+FDA+Inspectors+(ONLINE+EVENT%3A+April+7%2C+2025+%26+ON-DEMAND)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/1mbe8o<\/a>\n<\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong>\n<\/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.\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=\"m&#97;&#105;&#108;&#x74;&#x6f;&#x3a;pr&#101;&#115;&#x73;&#x40;&#x72;&#x65;se&#97;&#114;&#x63;&#x68;&#x61;&#x6e;d&#109;&#97;&#114;&#x6b;&#x65;&#x74;s&#46;&#99;&#111;&#109;\" rel=\"nofollow\" shape=\"rect\">&#x70;&#114;e&#x73;&#x73;&#64;r&#x65;&#115;e&#x61;&#x72;&#99;h&#x61;&#110;d&#x6d;&#x61;&#114;k&#x65;&#x74;&#115;&#x2e;&#x63;&#111;m<\/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;Data Integrity and Document Management Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. Document management and data integrity are a key focus of regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-and-document-management-training-course-a-key-focus-of-regulatory-inspections-with-both-eu-and-fda-inspectors-online-event-april-7-2025-on-demand-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-60989","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharma Data Integrity and Document Management Training Course: A Key Focus of Regulatory Inspections with Both EU and FDA Inspectors (ONLINE EVENT: April 7, 2025 &amp; ON-DEMAND) - 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\/pharma-data-integrity-and-document-management-training-course-a-key-focus-of-regulatory-inspections-with-both-eu-and-fda-inspectors-online-event-april-7-2025-on-demand-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma Data Integrity and Document Management Training Course: A Key Focus of Regulatory Inspections with Both EU and FDA Inspectors (ONLINE EVENT: April 7, 2025 &amp; ON-DEMAND) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Data Integrity and Document Management Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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