{"id":62502,"date":"2026-01-15T22:05:59","date_gmt":"2026-01-15T21:05:59","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-auditor-masterclass-training-course-department-level-audit-strategies-critical-findings-and-regulatory-expectations-online-event-apr-22nd-apr-23rd-2026-researchandmark\/"},"modified":"2026-01-15T22:05:59","modified_gmt":"2026-01-15T21:05:59","slug":"pharma-data-integrity-auditor-masterclass-training-course-department-level-audit-strategies-critical-findings-and-regulatory-expectations-online-event-apr-22nd-apr-23rd-2026-researchandmark","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-auditor-masterclass-training-course-department-level-audit-strategies-critical-findings-and-regulatory-expectations-online-event-apr-22nd-apr-23rd-2026-researchandmark\/","title":{"rendered":"Pharma Data Integrity Auditor Masterclass Training Course: Department-Level Audit Strategies, Critical Findings, and Regulatory Expectations (Online Event: Apr 22nd &#8211; Apr 23rd, 2026) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6173527\/data-integrity-auditor-masterclass-training-course?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=rx3bd5&amp;utm_campaign=2132846+-+Pharma+Data+Integrity+Auditor+Masterclass+Training+Course%3A+Department-Level+Audit+Strategies%2C+Critical+Findings%2C+and+Regulatory+Expectations+(Online+Event%3A+Apr+22nd+-+Apr+23rd%2C+2026)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">&#8220;Data Integrity Auditor Masterclass Training Course (Apr 22nd &#8211; Apr 23rd, 2026)&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260115076242\/en\/2693648\/21\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260115076242\/en\/2693648\/21\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260115076242\/en\/2693648\/21\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260115076242\/en\/2693648\/21\/logo.jpg\"><\/a><\/p>\n<p>\n<strong>Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities.<\/strong><\/p>\n<p>\nAlthough data integrity has started to gain importance in recent years, its history dates back approximately 30 years. Data integrity breaches at Barr Laboratories and later Able reveal this issue is older than it seems. As the health authorities began to question data integrity in audits more and more, pharmaceutical manufacturers started to increase their focus on data integrity, especially in GMP audits, and they started to seek ways to train their internal audit teams with this in mind. This approach acts to detect the deficiencies and deviations that will be found in internal audits prior to the health authority audits.<\/p>\n<p>\nAlthough there are numerous data integrity training courses available, the training rarely discusses the audits in detail, which leaves companies trying to solve their problems with a little guesswork based on their own knowledge and experience.<\/p>\n<p>\nIn this course, the concept of data integrity will be discussed from the perspective of GxP audits, and practical advice for successful data integrity audits will be provided. Important guidance about data integrity concepts and guidelines will be covered, and the skills required by personnel performing the audits will be discussed.<\/p>\n<p>\nThe programme will also advise in which departments data integrity audits should be carried out. Data integrity audits of the; warehouse, production, quality control, quality assurance, critical utilities, and engineering departments in pharmaceutical production facilities will be covered, with sample applications and question lists, and the most critical audit findings encountered in health authority audits will be examined. During this two-day training programme, the participants will analyse case studies and scenarios, which will aid the learning process.<\/p>\n<p>\n<strong>Benefits of attending<\/strong><\/p>\n<ul>\n<li>\n<strong>Learn<\/strong> the requirements of data integrity audits and health authority expectations<\/li>\n<li>\n<strong>Evaluate<\/strong> the concept of data integrity from a completely different perspective<\/li>\n<li>\n<strong>Understand<\/strong> the requirements of the role and necessary skills of the data integrity auditor<\/li>\n<li>\n<strong>Explore<\/strong> how to audit and prepare for external data integrity audits in the following departments; warehouse, manufacturing, quality control, quality assurance, critical utilities, and engineering<\/li>\n<\/ul>\n<p>\n<strong>At the end of the course, there will be a short assessment exam with case studies and audit scenarios which will be analysed during the course, and those delegates who are successful in the assessment exam will receive the title of &#8216;Certified Data Integrity Auditor&#8217;.<\/strong><\/p>\n<p>\n<strong>Certifications:<\/strong><\/p>\n<ul>\n<li>\nCPD: 12 hours for your records<\/li>\n<li>\nCertificate of completion<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong><\/p>\n<p>\n<strong>Personnel from the following departments will benefit from this course:<\/strong><\/p>\n<ul>\n<li>\nQuality assurance and quality control<\/li>\n<li>\nValidation<\/li>\n<li>\nR&amp;D<\/li>\n<li>\nAudit<\/li>\n<li>\nRegulatory<\/li>\n<li>\nIT<\/li>\n<li>\nWarehouse and supply chain<\/li>\n<li>\nEngineering<\/li>\n<li>\nProcurement<\/li>\n<\/ul>\n<p>\nAs well as:<\/p>\n<ul>\n<li>\nHealth authority inspectors<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong><\/p>\n<p>\n<strong>Day 1<\/strong><\/p>\n<p>\n<strong>GMP guidelines and regulations for data integrity (DI)<\/strong><\/p>\n<ul>\n<li>\nPharmaceutical Inspection Co-operation Scheme (PIC\/S), EU, WHO, MHRA, FDA data integrity regulations<\/li>\n<li>\nParenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE)<\/li>\n<li>\nAssociation for Professionals in Infection Control (APIC), International Pharmaceutical Excipients Council (IPEC) Guidelines<\/li>\n<li>\nRegulatory inspection &#8211; focus on data integrity (DI)<\/li>\n<li>\nHow to prepare your facility for regulatory inspection<\/li>\n<li>\nHow to prepare SMEs for DI questions<\/li>\n<\/ul>\n<p>\n<strong>Data integrity principles<\/strong><\/p>\n<ul>\n<li>\nWhat is ALCOA and ALCOA + (Attributable, Legible, Contemporaneous, Original &amp; Accurate)<\/li>\n<li>\nBeyond ALCOA<\/li>\n<\/ul>\n<p>\n<strong>Data integrity Issues in pharmaceutical companies<\/strong><\/p>\n<ul>\n<li>\nHow to manage DI in manufacturing<\/li>\n<li>\nHow to manage DI in laboratories<\/li>\n<li>\nHow to manage DI in warehouse &amp; logistics<\/li>\n<li>\nHow to manage DI in the supply chain<\/li>\n<\/ul>\n<p>\n<strong>FDA&#8217;s pre-approval inspection (PAI) and data integrity issues<\/strong><\/p>\n<ul>\n<li>\nWhat is the most important thing in PAI and DI?<\/li>\n<\/ul>\n<p>\n<strong>Audit planning and team building<\/strong><\/p>\n<ul>\n<li>\nHow to prepare a risk based DI audit plan?<\/li>\n<li>\nHow to select the DI audit team?<\/li>\n<li>\nHow to be a good DI auditor?<\/li>\n<\/ul>\n<p>\n<strong>Hints, tips and clues to performing successful DI audits<\/strong><\/p>\n<p>\n<strong>Virtual DI audits<\/strong><\/p>\n<ul>\n<li>\nDI Gap analysis<\/li>\n<li>\nDI checklist<\/li>\n<\/ul>\n<p>\n<strong>Workshop 1: data Integrity sourcing to laboratory equipment<\/strong><\/p>\n<p>\n<strong>Day 2<\/strong><\/p>\n<p>\n<strong>DI auditing of warehouse and critical utilities<\/strong><\/p>\n<p>\n<strong>DI auditing of manufacturing<\/strong><\/p>\n<ul>\n<li>\nDI auditing of calibrations<\/li>\n<\/ul>\n<p>\n<strong>DI auditing of an analytical chemistry laboratory<\/strong><\/p>\n<ul>\n<li>\nChromatography data system<\/li>\n<li>\nChromatography falsification<\/li>\n<li>\nDI audit of stability<\/li>\n<li>\nCan we audit audit trails?<\/li>\n<li>\nCan we detect DI risks?<\/li>\n<\/ul>\n<p>\n<strong>DI auditing of a microbiology laboratory<\/strong><\/p>\n<ul>\n<li>\nDI auditing of endotoxin testing<\/li>\n<li>\nRevealing DI breaches in a microbiology laboratory<\/li>\n<\/ul>\n<p>\n<strong>Supplier DI auditing<\/strong><\/p>\n<ul>\n<li>\nAPI DI audits<\/li>\n<li>\nExcipient DI audits<\/li>\n<\/ul>\n<p>\n<strong>Electronic records and electronic signatures (ERES) DI auditing<\/strong><\/p>\n<ul>\n<li>\nStandard operating procedure (SOP) for electronic audit trail review<\/li>\n<li>\nAudit trail review &#8211; Fourier Transform Infrared (FT-IR)<\/li>\n<li>\nAudit trail review questions<\/li>\n<li>\nE-records self-inspection<\/li>\n<\/ul>\n<p>\n<strong>IT Infrastructure and cloud DI auditing<\/strong><\/p>\n<ul>\n<li>\nSystem security, data generation, back-up and spreadsheets<\/li>\n<li>\nStand alone systems, and DI audits<\/li>\n<\/ul>\n<p>\n<strong>Workshop 2: data falsification investigation<\/strong><\/p>\n<p>\n<strong>DI audit report preparation and distribution<\/strong><\/p>\n<p>\n<strong>Case Studies and lessons learnt from regulatory inspections<\/strong><\/p>\n<p>\n<strong>Exam<\/strong><\/p>\n<p>\n<strong>Speakers:<br \/>\n<br \/><\/strong>Mustafa Edik<br \/>\n<br \/>Independent GMP Consultant and Auditor<\/p>\n<p>\nAfter graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German Pharmaceutical Company. After 15 years of working as a Quality Assurance Assistant Manager, Laboratory Supervisor, Pharmaceutical Quality Management Systems, and GMP Lead Auditor, he decided to continue his career as a Consultant. He has served the Turkish Atomic Energy Authority (TAEA) as Principal GMP Auditor and Consultant for 6 years. TAEA was audited by the Republic of Turkey Ministry of Health and granted GMP Certificate for 5 Radiopharmaceuticals. This success has won great acclaim from all health authorities and industry.<\/p>\n<p>\nHe has prepared and presented various training courses and workshops to more than 8000 individuals from 150 International and local Pharmaceutical, Medical Device, and Cosmetics companies on GMP, GDP and Pharmaceutical Quality Management Systems. He has taken part in several International Pharmaceutical Facility Establishment projects as GMP Consultant and has also set up various Quality Management Systems for Local Pharmaceutical and Medical Device Companies.<\/p>\n<p>\nWhile he was the Vice President of Quality and Technical Operations at a Quality Academia Training and Consultancy firm, he acquired and converted it into a 100 % Turkish Company. As the only IRCA Certificated Pharmaceutical Quality Management Systems and GMP Lead Auditor in Turkey, he currently conducts API, Excipient, Packaging Materials Suppliers and Manufacturers, Third Party Logistics Service Providers, Sterile and Non-Sterile Manufacturing Facilities Audits according to FDA, EMA, PIC \/S, TMMDA, MHRA, TGA Health Canada, and WHO regulations and guidelines.<\/p>\n<p>\nHe finished his second university degree in Biopharmaceutical Sciences BSc (Hons) at Atlantic Technological University &#8211; Ireland. He is the author of chapter 6 of the book published by PDA named &#8220;Good Distribution Practices&#8221; and he is preparing his latest book on &#8216;GMP Audits&#8217; which will be published by Taylor &amp; Francis in 2023.<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6173527\/data-integrity-auditor-masterclass-training-course?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=rx3bd5&amp;utm_campaign=2132846+-+Pharma+Data+Integrity+Auditor+Masterclass+Training+Course%3A+Department-Level+Audit+Strategies%2C+Critical+Findings%2C+and+Regulatory+Expectations+(Online+Event%3A+Apr+22nd+-+Apr+23rd%2C+2026)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/rn7l2d<\/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=\"&#x6d;&#x61;&#105;&#108;to&#x3a;&#x70;&#x72;&#101;ss&#x40;&#x72;&#x65;&#115;&#101;a&#x72;&#x63;&#x68;&#97;&#110;d&#x6d;&#x61;&#x72;&#107;&#101;ts&#x2e;&#x63;&#x6f;&#109;\" rel=\"nofollow\" shape=\"rect\">&#x70;&#x72;&#x65;&#x73;&#x73;&#x40;&#x72;&#x65;&#x73;&#x65;&#x61;&#x72;&#x63;&#x68;&#x61;&#x6e;&#x64;&#x6d;&#x61;&#x72;&#x6b;&#x65;&#x74;&#x73;&#x2e;&#x63;&#x6f;&#x6d;<\/a><\/p>\n<p>\nFor 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;Data Integrity Auditor Masterclass Training Course (Apr 22nd &#8211; Apr 23rd, 2026)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/pharma-data-integrity-auditor-masterclass-training-course-department-level-audit-strategies-critical-findings-and-regulatory-expectations-online-event-apr-22nd-apr-23rd-2026-researchandmark\/\">[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-62502","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 Auditor Masterclass Training Course: Department-Level Audit Strategies, Critical Findings, and Regulatory Expectations (Online Event: Apr 22nd - Apr 23rd, 2026) - 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-auditor-masterclass-training-course-department-level-audit-strategies-critical-findings-and-regulatory-expectations-online-event-apr-22nd-apr-23rd-2026-researchandmark\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma Data Integrity Auditor Masterclass Training Course: Department-Level Audit Strategies, Critical Findings, and Regulatory Expectations (Online Event: Apr 22nd - Apr 23rd, 2026) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Data Integrity Auditor Masterclass Training Course (Apr 22nd &#8211; Apr 23rd, 2026)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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Apr 23rd, 2026)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. Data integrity has received more attention than ever before in the last decade and has become the most critical audit topic for health authorities. Although data integrity has started to gain importance in recent ... 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