{"id":48800,"date":"2022-09-26T16:01:43","date_gmt":"2022-09-26T14:01:43","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/analytical-instrument-qualification-and-system-validation-course-october-27-28-2022-researchandmarkets-com\/"},"modified":"2022-09-26T16:01:43","modified_gmt":"2022-09-26T14:01:43","slug":"analytical-instrument-qualification-and-system-validation-course-october-27-28-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/analytical-instrument-qualification-and-system-validation-course-october-27-28-2022-researchandmarkets-com\/","title":{"rendered":"Analytical Instrument Qualification and System Validation Course (October 27-28, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5653619\/analytical-instrument-qualification-and-system?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nlkgsk&amp;utm_campaign=1754931+-+Analytical+Instrument+Qualification+and+System+Validation+Course+(October+27-28%2C+2022)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Analytical Instrument Qualification and System Validation&#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\/20220926005545\/en\/1582500\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220926005545\/en\/1582500\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national and international regulatory bodies.\n<\/p>\n<p>\nThe course not only ensures a full understanding of the regulations and guidelines for equipment and records but helps attendees to develop a risk-based approach to compliance. Interactive exercises will be dispersed into and between the presentations.\n<\/p>\n<p>\n<strong>Learning Objectives:<\/strong>\n<\/p>\n<ul>\n<li>\nLearn about the regulatory background and requirements for equipment qualification according to USP &lt;1058&gt; and computer system validation according to GAMP 5\n<\/li>\n<li>\nBe able to explain the difference between equipment calibration, qualification and system validation\n<\/li>\n<li>\nLearn which equipment\/systems need to be qualified or validated\n<\/li>\n<li>\nBe able to allocate equipment and systems to USP &lt;1058&gt; and GAMP 5 categories and to design and execute qualification\/validation protocols accordingly\n<\/li>\n<li>\nUnderstand the logic and principles of instrument qualification and system validation from planning to reporting\n<\/li>\n<li>\nBe able to develop a qualification and validation strategy\n<\/li>\n<li>\nUnderstand how to archive raw data from hybrid systems: electronic vs. paper\n<\/li>\n<li>\nBe able to define and demonstrate regulatory compliance to auditors and inspectors\n<\/li>\n<li>\nBe able to develop inspection-ready documentation\n<\/li>\n<li>\nLearn how to ensure, document and audit the integrity of GMP records\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nIT\/IS managers and system administrators\n<\/li>\n<li>\nQA managers and personnel\n<\/li>\n<li>\nLaboratory managers and supervisors\n<\/li>\n<li>\nAnalysts\n<\/li>\n<li>\nValidation specialists\n<\/li>\n<li>\nSoftware developers\n<\/li>\n<li>\nRegulatory affairs\n<\/li>\n<li>\nTraining departments\n<\/li>\n<li>\nDocumentation departments\n<\/li>\n<li>\nConsultants\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Day 01 (10:00 AM &#8211; 5:00 PM EDT)<\/strong>\n<\/p>\n<p>\n<strong>10.00 AM &#8211; 10.45 AM &#8211; Requirements and approaches for Analytical Instrument Qualification<\/strong>\n<\/p>\n<ul>\n<li>\nFDA\/EU, PIC\/S requirements\n<\/li>\n<li>\nQualification\/calibration issues in FDA inspections\n<\/li>\n<li>\nUSP General Chapter &lt;1058&gt;: Analytical Instrument Qualification\n<\/li>\n<li>\nThe instrument qualification lifecycle\n<\/li>\n<li>\nPrioritizing calibration\/qualification activities\n<\/li>\n<\/ul>\n<p>\n<strong>10.45 AM &#8211; 11.30 AM &#8211; Qualification in Practice<\/strong>\n<\/p>\n<ul>\n<li>\nUser requirement specifications\n<\/li>\n<li>\nInstallation qualification\n<\/li>\n<li>\nOperational qualification\n<\/li>\n<li>\nPreparing inspection-ready documentation\n<\/li>\n<\/ul>\n<p>\n<strong>11:30 AM &#8211; 11:45 AM &#8211; Break<\/strong>\n<\/p>\n<p>\n<strong>11.45 AM &#8211; 12.45 PM &#8211; Testing and deviation handling<\/strong>\n<\/p>\n<ul>\n<li>\nDeveloping test protocols\n<\/li>\n<li>\nDocumenting test evidence\n<\/li>\n<li>\nReview and approval of test results\n<\/li>\n<li>\nHandling deviations\n<\/li>\n<\/ul>\n<p>\n<strong>12:45 PM &#8211; 1:15 PM &#8211; Lunch<\/strong>\n<\/p>\n<p>\n<strong>1.15 PM &#8211; 2.30 PM &#8211; Retrospective qualification and Requalification<\/strong>\n<\/p>\n<ul>\n<li>\nQualification of existing systems\n<\/li>\n<li>\nLeveraging past experience\n<\/li>\n<li>\nTime-based requalification\n<\/li>\n<li>\nEvent-based requalification\n<\/li>\n<li>\nWhat and how much to test &#8211; risk-based approach\n<\/li>\n<\/ul>\n<p>\n<strong>2.30 PM &#8211; 3.15 PM &#8211; Equipment Maintenance and Change Control<\/strong>\n<\/p>\n<ul>\n<li>\nPreventive maintenance; tasks, documentation\n<\/li>\n<li>\nPlanned and unplanned changes\n<\/li>\n<li>\nChanging hardware, firmware, documentation\n<\/li>\n<li>\nDefinition and handling of like-for-like changes.\n<\/li>\n<li>\nHandling changes made by vendors\n<\/li>\n<\/ul>\n<p>\n<strong>3.15 PM &#8211; 4.00 PM: Type and extend of qualification for USP Instrument Categories<\/strong>\n<\/p>\n<ul>\n<li>\nThe approach and benefits of instrument categories\n<\/li>\n<li>\nHow to identify the correct category: A, B, C\n<\/li>\n<li>\nType and extent of qualification for each category\n<\/li>\n<li>\nRequired procedures and qualification deliverables\n<\/li>\n<li>\nResponsibilities for instrument qualification\n<\/li>\n<\/ul>\n<p>\n<strong>4:00 PM &#8211; 4:15 PM &#8211; Break<\/strong>\n<\/p>\n<p>\n<strong>4.15 PM &#8211; 5.00 PM &#8211; Requirements and approaches for GMP Computer Systems<\/strong>\n<\/p>\n<ul>\n<li>\n21 CFR Part 211, Part 11, PIC\/S, EU Annex 11\n<\/li>\n<li>\nMost critical inspection findings\n<\/li>\n<li>\nWhich systems need to be validated\n<\/li>\n<li>\nGAMP 5: A Risk based Approach to Laboratory Computerized Systems\n<\/li>\n<li>\nExamples for risk assessment of computer systems\n<\/li>\n<li>\nValidation of Laboratory Computer systems\n<\/li>\n<li>\nWriting a validation project plan\n<\/li>\n<li>\nIntegrating GAMP 5 with USP &lt;1058&gt; for instrument and computer system validation\n<\/li>\n<li>\nWriting a validation report\n<\/li>\n<\/ul>\n<p>\n<strong>Day 02 (10:00 AM &#8211; 5:00 PM EDT)<\/strong>\n<\/p>\n<p>\n<strong>10.00 AM &#8211; 10.15 AM &#8211; Questions and answers from Day 1<\/strong>\n<\/p>\n<p>\n<strong>10.15 AM &#8211; 11.00 AM &#8211; Validation and Use of Excel in the QC Laboratory<\/strong>\n<\/p>\n<ul>\n<li>\nDesigning spreadsheets for compliance\n<\/li>\n<li>\nValidation approach for spreadsheets &#8211; single and multiple-use spreadsheets\n<\/li>\n<li>\nWhen, what, and how much to test?\n<\/li>\n<li>\nGAMP 5 recommendations\n<\/li>\n<\/ul>\n<p>\nHow to ensure spreadsheet data integrity\n<\/p>\n<p>\n<strong>11:00 AM &#8211; 11:15 AM &#8211; Break<\/strong>\n<\/p>\n<p>\n<strong>11.15 AM &#8211; 12.15 PM &#8211; Configuration management and change control<\/strong>\n<\/p>\n<ul>\n<li>\nThe IEEE standard for configuration management\n<\/li>\n<li>\nThe change control process for planned changes\n<\/li>\n<li>\nUnplanned changes\n<\/li>\n<li>\nUpgrading software\n<\/li>\n<li>\nWhat to test after changes\n<\/li>\n<li>\nHow to document changes\n<\/li>\n<\/ul>\n<p>\n<strong>12.15 PM &#8211; 1.00 PM &#8211; Periodic revalidation of chromatography data systems<\/strong>\n<\/p>\n<ul>\n<li>\nThe approach and practice of periodic review\n<\/li>\n<li>\nUsing periodic reviews to reduce the frequency of revalidation\n<\/li>\n<li>\nCriteria for time-based revalidation\n<\/li>\n<li>\nIncidents requiring revalidation\n<\/li>\n<li>\nValidation tasks after installing security and other patches\n<\/li>\n<\/ul>\n<p>\n<strong>1:00 PM &#8211; 1:45 PM &#8211; Lunch<\/strong>\n<\/p>\n<p>\n<strong>1.45 PM &#8211; 2.30 PM &#8211; Handling raw data and other laboratory records<\/strong>\n<\/p>\n<ul>\n<li>\nDefinition of raw data: electronic vs. paper\n<\/li>\n<li>\nAcquisition and recording of raw data\n<\/li>\n<li>\nHow to make accurate and complete copies of raw data\n<\/li>\n<li>\nChanging records\n<\/li>\n<li>\nArchiving of raw data and ready retrieval\n<\/li>\n<\/ul>\n<p>\n<strong>2.30 PM &#8211; 3.00 PM &#8211; Ensuring Integrity and Security of GMP data<\/strong>\n<\/p>\n<ul>\n<li>\nMost frequent security and integrity issues\n<\/li>\n<li>\nThe importance of electronic audit trails\n<\/li>\n<li>\nReview of electronic audit trails: who, what, when, and how\n<\/li>\n<\/ul>\n<p>\n<strong>3:00 PM &#8211; 3:15 PM &#8211; Break<\/strong>\n<\/p>\n<p>\n<strong>3:15 PM &#8211; 4.30 PM &#8211; Auditing Laboratory Computer Systems<\/strong>\n<\/p>\n<ul>\n<li>\nUsing FDA inspection practice\n<\/li>\n<li>\nImportance of data governance policy and controls\n<\/li>\n<li>\nPreparing inspection-ready documentation\n<\/li>\n<li>\nResponding to typical inspectional\/audit observations\n<\/li>\n<\/ul>\n<p>\n<strong>4.30 PM &#8211; 5.00 PM &#8211; Wrap up &#8211; Final questions and answers<\/strong>\n<\/p>\n<p>\n<strong>Speaker<\/strong>\n<\/p>\n<p>\nMark Powell\n<\/p>\n<p>\nFellow\n<\/p>\n<p>\nRoyal Society of Chemistry\n<\/p>\n<p>\nDr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years&#8217; experience as an analytical chemist. Mark was Honorary Treasurer of the RSC&#8217;s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.\n<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5653619\/analytical-instrument-qualification-and-system?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nlkgsk&amp;utm_campaign=1754931+-+Analytical+Instrument+Qualification+and+System+Validation+Course+(October+27-28%2C+2022)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/881rkb<\/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=\"m&#97;&#x69;&#x6c;t&#111;&#x3a;&#x70;r&#101;&#x73;&#x73;&#64;&#114;&#x65;&#x73;e&#97;&#x72;&#x63;h&#97;&#110;&#x64;&#x6d;a&#114;&#x6b;&#x65;t&#115;&#x2e;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;e&#115;&#x73;&#64;&#114;&#x65;s&#x65;&#x61;&#114;&#x63;h&#97;&#x6e;d&#109;&#x61;r&#x6b;&#x65;&#116;&#x73;&#x2e;&#99;&#x6f;m<\/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;Analytical Instrument Qualification and System Validation&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/analytical-instrument-qualification-and-system-validation-course-october-27-28-2022-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-48800","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>Analytical Instrument Qualification and System Validation Course (October 27-28, 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\/analytical-instrument-qualification-and-system-validation-course-october-27-28-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Analytical Instrument Qualification and System Validation Course (October 27-28, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Analytical Instrument Qualification and System Validation&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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training has been added to ResearchAndMarkets.com&#8217;s offering. This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidance documents from national ... 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