{"id":51233,"date":"2022-11-24T16:02:14","date_gmt":"2022-11-24T15:02:14","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/2-day-pharmaceutical-analytical-method-validation-verification-and-transfer-course-december-13-14-2022-researchandmarkets-com\/"},"modified":"2022-11-24T16:02:14","modified_gmt":"2022-11-24T15:02:14","slug":"2-day-pharmaceutical-analytical-method-validation-verification-and-transfer-course-december-13-14-2022-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/2-day-pharmaceutical-analytical-method-validation-verification-and-transfer-course-december-13-14-2022-researchandmarkets-com\/","title":{"rendered":"2 Day Pharmaceutical Analytical Method Validation, Verification and Transfer Course (December 13-14, 2022) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5680904\/analytical-method-validation-verification-and?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=lvwpls&amp;utm_campaign=1780273+-+2+Day+Pharmaceutical+Analytical+Method+Validation%2C+Verification+and+Transfer+Course+(December+13-14%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Analytical Method Validation, Verification and Transfer&#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\/20221124005256\/en\/1646846\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221124005256\/en\/1646846\/21\/logo.jpg\"><\/a><\/p>\n<p>\nReliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations. Therefore, meaningful experimental designs including system suitability parameters must be planned for the intended use of the procedure.\n<\/p>\n<p>\nIn this course, general guideline for the determination of the analytical characteristics for different types of validation procedures is highlighted for the analysis of both the drug substance and drug product. The factors to consider for verification of the compendial procedures will also be discussed.\n<\/p>\n<p>\nIn addition, different approaches for the transfer of analytical procedure from one lab (transferring) to other lab(s) (receiving) under different circumstances will be covered. Other related topics for obtaining reliable data will also be discussed. These topics include analytical instrument qualification as well as how to set, handle and monitor specifications.\n<\/p>\n<p>\nDue to global nature of pharmaceutical industry, other quality topics on both regulatory (ICH) and compendial (USP) harmonization are also covered. These topics are valuable for scientists directly or indirectly involved with the drug development, analysis. stability studies or regulatory\/compendial submissions.\n<\/p>\n<p>\n<strong>Learning Objectives<\/strong>\n<\/p>\n<ul>\n<li>\nDrug Approval Process and Regulatory Requirements (private standards)\n<\/li>\n<li>\nPharmacopeias and Compendial Approval Process (public standards)\n<\/li>\n<li>\nCompendial Harmonization Process\n<\/li>\n<li>\nChromatography System Suitability Requirements\n<\/li>\n<li>\nAllowed Adjustments of Chromatographic System Parameters\n<\/li>\n<li>\nAnalytical Instrument Qualifications including DQ, IQ, OQ, PQ\n<\/li>\n<li>\nAnalytical Method Validation\n<\/li>\n<li>\nAnalytical Method Verification\n<\/li>\n<li>\nAnalytical Method Transfer\n<\/li>\n<li>\nAlternative to Official procedure and options\n<\/li>\n<li>\nAnalytical Procedure Life Cycle\n<\/li>\n<li>\nHow to Set Specifications and how to handle out-of-specification (OOS) and out-of-trend (OOT) results\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nContract Laboratories (CRO)\n<\/li>\n<li>\nAcademia (pharmacy, Pharmaceutical Industry, Pharmaceutical, Chemistry)\n<\/li>\n<li>\nGovernment (FDA or regulatory authorities)\n<\/li>\n<li>\nQuality Analysis Managers and Personnel\n<\/li>\n<li>\nControlling Personnel\n<\/li>\n<li>\nAnalytical and or Formulation Chemists\n<\/li>\n<li>\nQuality Control Managers and Personnel\n<\/li>\n<li>\nLab Supervisors and Managers\n<\/li>\n<li>\nCompendial Liaisons\n<\/li>\n<li>\nSenior or Graduate students (chemistry, pharmaceutical, pharmacy)\n<\/li>\n<li>\nPharmaceutical scientists\/Pharmacists working in Industry\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>DAY 01<\/strong>\n<\/p>\n<ul>\n<li>\nSeminar objectives review, expectations, and scope.\n<\/li>\n<li>\nDrug Approval Process and Regulatory (FDA) Requirements (private standards)\n<\/li>\n<li>\nPharmacopeias and Compendial (USP) Approval Process (public standards)\n<\/li>\n<li>\nCompendial Harmonization Process\n<\/li>\n<li>\nChromatography System Suitability Requirements\n<\/li>\n<li>\nAllowed Adjustments of Chromatographic System Parameters\n<\/li>\n<li>\nAnalytical Instrument Qualifications\n<\/li>\n<li>\nInstrument Categories\n<\/li>\n<li>\nQualification Phases (DQ, IQ, OQ, PQ)\n<\/li>\n<li>\nAnalytical Method Validation (typical validation parameters)\n<\/li>\n<li>\nSpecificity\n<\/li>\n<li>\nPrecision\/Accuracy\n<\/li>\n<li>\nLinearity\/Range\n<\/li>\n<li>\nLOD and LOQ\n<\/li>\n<li>\nAnalytical Method Verification\n<\/li>\n<li>\nFDA and USP Requirements\n<\/li>\n<li>\nFactors to Consider\n<\/li>\n<li>\nAnalytical Method Transfer\n<\/li>\n<li>\nDifferent Approaches\n<\/li>\n<li>\nSummary and Review\n<\/li>\n<\/ul>\n<p>\n<strong>DAY 02<\/strong>\n<\/p>\n<ul>\n<li>\nInvestigative Procedure Life Cycle<\/p>\n<ul>\n<li>\nSetting Specifications FDA regulations and ICH guidelines (Q6A)\n<\/li>\n<li>\nOut-of-Specification (OOS)\n<\/li>\n<li>\nOut of Trend (OOT)\n<\/li>\n<li>\nHow to handle OOS and OOT?\n<\/li>\n<\/ul>\n<\/li>\n<li>\nSummary and Review\n<\/li>\n<\/ul>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5680904\/analytical-method-validation-verification-and?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=lvwpls&amp;utm_campaign=1780273+-+2+Day+Pharmaceutical+Analytical+Method+Validation%2C+Verification+and+Transfer+Course+(December+13-14%2C+2022)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/lf88xx<\/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=\"mail&#116;&#111;&#58;&#112;&#114;&#101;&#115;&#x73;&#x40;&#x72;&#x65;&#x73;&#x65;&#x61;&#x72;&#x63;hand&#109;&#97;&#114;&#107;&#101;&#116;&#115;&#x2e;&#x63;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;r&#x65;&#115;&#x73;&#64;&#x72;&#x65;s&#x65;&#97;&#x72;&#99;&#x68;&#97;n&#x64;&#109;&#x61;&#114;&#x6b;&#101;t&#x73;&#46;&#x63;&#111;&#x6d;<\/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 Method Validation, Verification and Transfer&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. Reliable analytical results are necessary to make informed decision about the quality and safety of the products in the pharmaceutical industry. In addition, such analytical data are required for regulatory submissions in support of the drug product registrations. Therefore, meaningful &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/2-day-pharmaceutical-analytical-method-validation-verification-and-transfer-course-december-13-14-2022-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-51233","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>2 Day Pharmaceutical Analytical Method Validation, Verification and Transfer Course (December 13-14, 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\/2-day-pharmaceutical-analytical-method-validation-verification-and-transfer-course-december-13-14-2022-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"2 Day Pharmaceutical Analytical Method Validation, Verification and Transfer Course (December 13-14, 2022) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Analytical Method Validation, Verification and Transfer&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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