{"id":72,"date":"2017-07-12T05:54:00","date_gmt":"2017-07-12T05:54:00","guid":{"rendered":"http:\/\/iqm-consulting.com\/index.php\/services\/"},"modified":"2020-11-18T09:41:35","modified_gmt":"2020-11-18T09:41:35","slug":"services","status":"publish","type":"page","link":"https:\/\/iqm-consulting.com\/index.php\/services\/","title":{"rendered":"Services"},"content":{"rendered":"\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t\t\t
<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t

Services<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t
\n\t\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t

Our Services<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t

Rendered services are fully compliant with the current normative references:<\/strong><\/p>\n

    \n
  • cGMP of the US FDA  (21CFR Part 211 and Part 820), and related guidance documents.<\/li>\n
  • ISO Standard ISO 9000, ISO 13485, ISO14971and ISO Standard defined on your Technical Files.<\/li>\n
  • EU GMP Part I, II, III guidance and annexes.<\/li>\n
  • Local GMP regulations on regulated markets, like, UK, Japan, Russia, Brazil, Korea,… <\/li>\n<\/ul>\n

    Our services include interim quality management support, QMS development and  implementation activities, non-compliance remediation plan, supplier audits services, handling of Regulatory and\/or customer inspections and a host of other QA \/ QC activities. These services include, but are not limited to, the following:<\/strong><\/p>\n

      \n
    • Strategic management consulting relative to your Quality Systems, QA\/QC organization and quality budget and expenses.<\/li>\n
    • Quality Management System (QMS) development, enhancement or optimization by Lean Six Sigma principles.<\/li>\n
    • QMS alignment and Compliance with International Regulations and Standards. <\/li>\n
    • Facilitation and management of new ISO certification projects<\/li>\n
    • Assistance in selecting an EU Notified Body<\/li>\n
    • Regulatory\/customer audit preparation: pre-audit training, mock inspection, representation during audits (pre-approval, routine, follow-up compliance, \u00abfor-cause\u00bb).<\/li>\n
    •  Internal Compliance Audits (to your schedule, or independent \u201c3rd party\u201d)<\/li>\n
    • Supplier audits (quality\/ risk audit). Supplier qualification. Supplier rating programs.<\/li>\n
    • Independent Supplier failure investigations and problem solving.<\/li>\n
    • Handling of complex quality failure investigations in Media Fills, aseptic manufacturing process, recurrent deviations, OOS\/OOT, sterility testing, environmental control,… and root cause identification.<\/li>\n
    • Development, implementation and follow-up of remediation plans. <\/li>\n
    • Development of holistic action plans to audit findings (Warning letters, 483’s,…) or complex quality failure. <\/li>\n
    • Management of complex quality projects, like new facility authorization, new product introduction, tech transfer activities, parametric release, Data Integrity Compliance, manufacturing of sterile products, Continuous Process Verification,…<\/li>\n
    • Optimization of Master Batch Records\/ Device History Records (DHR)<\/li>\n
    • Risk Management \/ Risk Assessment \/ <\/span>FMEA – FMECA<\/li>\n
    • Complaint Handling System<\/li>\n
    • Acceptance Sampling and <\/span>SPC methodologies<\/li>\n<\/ul>\n

      IQM-Consulting will tailor our work to your particular needs, and in support of your particular time-frame. We will structure our work-efforts in a way that makes the most sense for you:<\/strong><\/p>\n

        \n
      • Remote document review and draft revisions.<\/li>\n
      • Single-event session (remote or on-site)<\/li>\n
      • Strategy meetings (remote or on-site)<\/li>\n
      • As-needed support (remote or on-site)<\/li>\n
      • Project-specific support (remote or on-site)<\/li>\n
      • Element-specific support (remote or on-site)<\/li>\n<\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

        Services Our Services Rendered services are fully compliant with the current normative references: cGMP of the US FDA  (21CFR Part 211 and Part 820), and related guidance documents. ISO Standard ISO 9000, ISO 13485, ISO14971and ISO Standard defined on your Technical Files. EU GMP Part I, II, III guidance and annexes. Local GMP regulations on […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"","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":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","theme-transparent-header-meta":"enabled","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":"","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":""}},"footnotes":""},"_links":{"self":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/pages\/72"}],"collection":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/comments?post=72"}],"version-history":[{"count":13,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/pages\/72\/revisions"}],"predecessor-version":[{"id":1998,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/pages\/72\/revisions\/1998"}],"wp:attachment":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/media?parent=72"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}