{"id":4991,"date":"2023-06-08T12:22:04","date_gmt":"2023-06-08T10:22:04","guid":{"rendered":"https:\/\/www.pharmaeducationcenter.it\/?post_type=product&p=4991"},"modified":"2026-04-17T11:57:51","modified_gmt":"2026-04-17T09:57:51","slug":"audit-inspection-pharmacovigilance","status":"publish","type":"product","link":"https:\/\/www.pharmaeducationcenter.it\/en\/trainings\/pharmacovigilance\/audit-inspection-pharmacovigilance\/","title":{"rendered":"Audit and Inspection in Pharmacovigilance"},"content":{"rendered":"

The training course \u201cAudit and Inspection in Pharmacovigilance\u201d will help the participant understand how well-designed and well-conducted pharmacovigilance audits allow pharmaceutical companies to identify any existing gaps or risks in their PV systems and procedures and to define activities and priorities for the continuous improvement of their PV quality systems.<\/p>\n

This has the aim to ensure compliance of the PV system to national and international legislation and recognized standards and to be ready to face GVP regulatory inspections. During the course, a deep review of the most important PV processes and interactions between internal and external stakeholders will outline more common areas of improvements according to auditors\/inspectors expectations.<\/p>\n","protected":false},"excerpt":{"rendered":"

The training course \u201cAudit and Inspection in Pharmacovigilance\u201d will help the participant understand how well-designed and well-conducted pharmacovigilance audits allow pharmaceutical companies to identify any existing gaps or risks in their PV systems and procedures and to define activities and priorities for the continuous improvement of their PV quality systems.<\/p>\n","protected":false},"featured_media":5002,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_joinchat":[]},"product_brand":[],"product_cat":[116,117,115,118],"product_tag":[],"class_list":{"0":"post-4991","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-pharmacovigilance","7":"product_cat-corsi-di-formazione","8":"product_cat-farmacovigilanza","9":"product_cat-trainings","10":"desktop-align-left","11":"tablet-align-left","12":"mobile-align-left","13":"ast-product-gallery-layout-horizontal-slider","14":"ast-product-gallery-with-no-image","15":"ast-magnify-disabled","16":"ast-product-single-variable","18":"first","19":"instock","20":"taxable","21":"shipping-taxable","22":"purchasable","23":"product-type-variable"},"acf":{"corso_new_label":false,"corso_promo_label":false,"corso_pdf_programma":"","corso_programma":"

Struttura del corso<\/h5>\r\n14.00 - 18.00 COURSE SESSION DAY 1\r\n14.00 - 18.00 COURSE SESSION DAY 2\r\n
Programma<\/h5>\r\n

DAY 1<\/em><\/h3>\r\n14.00 Introduction to the course<\/strong>\r\n\r\n14.10 What are the main regulatory requirements and the organization of the PV System?<\/strong>\r\n
    \r\n \t
  • Main requirements and key points<\/li>\r\n \t
  • Key PV processes<\/li>\r\n \t
  • Interactions with other company departments<\/li>\r\n \t
  • Q&A time<\/em><\/li>\r\n<\/ul>\r\n15.50\u00a0Coffe Break<\/strong>\r\n\r\n16.10 GVP Audit<\/strong>\r\n
      \r\n \t
    • Regulatory requirements<\/li>\r\n \t
    • Risk based approach<\/li>\r\n \t
    • Audit announcement, preparation and conduction<\/li>\r\n \t
    • CAPA plan monitoring<\/li>\r\n \t
    • KPIs on audit activities<\/li>\r\n<\/ul>\r\n17.40 Q&A Time<\/strong>\r\n18.00 Closure of day one<\/strong>\r\n

      <\/h3>\r\n

      DAY 2<\/em><\/h3>\r\n14.00\u00a0Focus on GVP Inspection requirements<\/strong>\r\n
        \r\n \t
      • Regulatory requirements<\/li>\r\n \t
      • Risk based approach<\/li>\r\n \t
      • Inspection announcement<\/li>\r\n \t
      • Q&A Time<\/em><\/li>\r\n<\/ul>\r\n15.30\u00a0Coffee Break<\/strong>\r\n\r\n15:50 GVP inspection readiness<\/strong>\r\n
          \r\n \t
        • Key points in the preparation of inspection<\/li>\r\n \t
        • Interaction with other company departments<\/li>\r\n \t
        • GVP inspection days<\/li>\r\n<\/ul>\r\n16.30 What are the main inspector\u2019s expectations?<\/strong>\r\n
            \r\n \t
          • Sharing of most common finding and experience<\/li>\r\n \t
          • Discussion<\/li>\r\n<\/ul>\r\n17:15 Key takeaways\r\n<\/strong>18:00 Closure of the course<\/strong>","corso_target":"
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            \r\n\r\nFor professionals working in the following areas:\r\n\u2022 Pharmacovigilance\r\n\u2022 Drug Safety and Risk Management\r\n\u2022 Regulatory Affairs\r\n\u2022 Clinical Research\r\n\u2022 Quality and Compliance\r\n\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>\r\n<\/div>","corso_competenze":[{"corso_competenze_item":"Understand the specific requirement of a Pharmacovigilance Quality System and implement or improve this process in their own organisation"},{"corso_competenze_item":"Learn the key phases of the pharmacovigilance audit both as an auditor and as an auditee"},{"corso_competenze_item":"Focus on most important interactions of a Pharmacovigilance System and processes usually reviewed during GVP audit and inspections"},{"corso_competenze_item":"Learn how to approach and face up a GVP audit"},{"corso_competenze_item":"Learn how to prepare organization for a GVP inspection understanding the regulatory expectations"}]},"_links":{"self":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product\/4991","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media\/5002"}],"wp:attachment":[{"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/media?parent=4991"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_brand?post=4991"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_cat?post=4991"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/www.pharmaeducationcenter.it\/en\/wp-json\/wp\/v2\/product_tag?post=4991"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}