{"id":48394,"date":"2022-09-14T18:01:40","date_gmt":"2022-09-14T16:01:40","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/auditing-analytical-laboratories-for-fda-compliance-webinar-researchandmarkets-com\/"},"modified":"2022-09-14T18:01:40","modified_gmt":"2022-09-14T16:01:40","slug":"auditing-analytical-laboratories-for-fda-compliance-webinar-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/auditing-analytical-laboratories-for-fda-compliance-webinar-researchandmarkets-com\/","title":{"rendered":"Auditing Analytical Laboratories for FDA Compliance Webinar &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5570912\/4-hour-virtual-seminar-on-auditing-analytical?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=5trl6l&amp;utm_campaign=1749700+-+Auditing+Analytical+Laboratories+for+FDA+Compliance+Webinar&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;4-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance&#8221;<\/a> webinar has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220914005713\/en\/1571751\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220914005713\/en\/1571751\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThere are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements, and the nature of work that the laboratory performs will be discussed.\n<\/p>\n<p>\nThe second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally. Different types of laboratories will require different auditors\/specialists. We will discuss the pitfalls that auditors can fall into, and what questions laboratories may expect to encounter.\n<\/p>\n<p>\n<strong>Why you should attend<\/strong>\n<\/p>\n<p>\nIt is necessary for a company to know if an analytical laboratory is capable of operating in compliance with GMP or other regulations. This is especially critical if the laboratory is a quality control laboratory whose test results will be used to support the release of a product to the public or to support an application for permission to market a product. The failure of a quality control laboratory to comply with regulations can result in the failure of a request for permission to market a product or a forced recall of a marketed product.\n<\/p>\n<p>\nIn extreme cases, a revocation of the permission to market a product may be the result. In any case, the inability to conform to regulations will result in a loss of confidence in the ability of the manufacturer to produce a product that meets quality and regulatory requirements, and, in turn, lead to a refusal to purchase a product.\n<\/p>\n<p>\nIt is critical that the audit of the laboratory be conducted in a professional manner, as a poor audit will waste money and lead to false confidence in the abilities of the audited laboratory whether it is internal or external to the company.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nPotential Auditors\n<\/li>\n<li>\nSupervisors who must initiate Audits\n<\/li>\n<li>\nLaboratory Supervisors and Workers\n<\/li>\n<li>\nQuality Assurance and Control Supervisors and Lead Workers\n<\/li>\n<li>\nSupervisory Management must select Contractors\n<\/li>\n<li>\nManagers\n<\/li>\n<li>\nDirectors\n<\/li>\n<li>\nVice Presidents who Supervise Quality Assurance\n<\/li>\n<li>\nQuality Control\n<\/li>\n<li>\nRegulatory Affairs Groups\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<ul>\n<li>\nChoosing who should be audited\n<\/li>\n<li>\nDeciding on the regulatory requirements\n<\/li>\n<li>\nSelecting the audit team\n<\/li>\n<li>\nContacting the laboratory and asking for the audit\n<\/li>\n<li>\nInitial interactions\n<\/li>\n<li>\nSetting up the audit file\n<\/li>\n<li>\nSetting dates for the audit\n<\/li>\n<li>\nTravel arrangements and lodging\n<\/li>\n<li>\nThe opening meeting\n<\/li>\n<li>\nThe actual audit. Be sure to walk through the lab\n<\/li>\n<li>\nTalk to the technicians\n<\/li>\n<li>\nAssess the instruments\n<\/li>\n<li>\nFollow the path of a sample and the test results\n<\/li>\n<li>\nData Integrity is an issue to consider\n<\/li>\n<li>\nAssessing data integrity issues\n<\/li>\n<li>\nTest reports and certificates of analysis\n<\/li>\n<li>\nThe team meeting\n<\/li>\n<li>\nThe closing meeting. All issues and potential observations must be discussed\n<\/li>\n<li>\nThe thank you letter. Be sure to give a date for the audit report\n<\/li>\n<li>\nResponses to the audit report\n<\/li>\n<li>\nClosing the audit\n<\/li>\n<\/ul>\n<p>\nFor more information about this webinar visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5570912\/4-hour-virtual-seminar-on-auditing-analytical?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=5trl6l&amp;utm_campaign=1749700+-+Auditing+Analytical+Laboratories+for+FDA+Compliance+Webinar&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/9mpkcn<\/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=\"&#x6d;&#x61;&#x69;&#x6c;&#x74;&#x6f;&#x3a;&#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;\" rel=\"nofollow noopener\" shape=\"rect\">p&#114;&#x65;&#x73;s&#64;&#114;&#x65;&#x73;e&#97;&#x72;&#x63;h&#97;&#110;&#x64;&#x6d;a&#114;&#x6b;&#x65;t&#115;&#46;&#x63;&#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;4-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/auditing-analytical-laboratories-for-fda-compliance-webinar-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-48394","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>Auditing Analytical Laboratories for FDA Compliance Webinar - 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\/auditing-analytical-laboratories-for-fda-compliance-webinar-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Auditing Analytical Laboratories for FDA Compliance Webinar - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;4-Hour Virtual Seminar on Auditing Analytical Laboratories for FDA Compliance&#8221; webinar has been added to ResearchAndMarkets.com&#8217;s offering. 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