{"id":40161,"date":"2025-05-21T20:23:07","date_gmt":"2025-05-21T20:23:07","guid":{"rendered":"https:\/\/www.oxfordcorp.com\/?p=40161"},"modified":"2025-05-21T20:24:07","modified_gmt":"2025-05-21T20:24:07","slug":"remediation-support-for-multinational-pharma-company","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/nl-d\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/","title":{"rendered":"Remediation Support for Multinational Pharma Company"},"content":{"rendered":"
INDUSTRY<\/strong>
\nLife Sciences<\/p>\n

SERVICES<\/strong>
\nRegulatory Compliance
\nEngagement Management
\nRemediation Support
\nFDA Inspection Preparedness<\/p>\n

SKILLS<\/strong>
\nQuality Assurance
\nMicrobiology
\nInspection Readiness
\nOperational Excellence
\nTraining
\nTechnical Writing<\/p>\n<\/div>\n

SITUATION<\/b><\/p>\n

Oxford\u2019s client, a multinational pharmaceutical and healthcare company, required a partner to support them through a remediation effort. The focus of the remediation stemmed from a backlog of deviations that needed to be investigated. Given the complexity and volume of the work, the client required a partner with deep technical expertise and experience driving robust compliance efforts to help companies through remediation efforts.<\/p>\n

SOLUTION<\/b><\/p>\n

Oxford was selected as our client\u2019s partner to take full ownership of the remediation initiative. We provided a team of 40 specialized consultants, working on-site, to support 7 workstreams; Deviation Investigation, Supplier Management, Learning & Development, Microbiology, Inspection Readiness, Operational Excellence, and Technical Writing. The Oxford team, who was supported by an Oxford Project Manager, utilized best-in-class root cause analysis tools and processes to conduct thorough investigations of more than 1,000 deviations in backlog and actively addressed the findings to prevent recurrence. To address these deviations the Oxford team conducted supplier reviews and issued notices, developed and trained employees on new SOPs, work instructions and quality & compliance training modules, conducted GEMBA walk-throughs and internal audits to prepare for FDA re-inspection, and provide coaching and guidance to client employees to abate future observations.<\/p>\n

RESULT<\/b><\/p>\n

The Oxford Deviation Investigation team addressed the deviation backlog by identifying and documenting root causes, CAPA\u2019s, and non-conformances. Our Supplier Management team conducted supplier reviews, issuing supplier non-conformances, and issuing supplier CAPA requests. The Learning & Development team developed and conducted training specific to newly written SOPs and work instructions as well as overall quality & compliance process enhancements. The Oxford Microbiologists supported production and facilities to instill preventive measures based on the deviation findings. Finally, our Inspection Readiness team conducted GEMBA walk-throughs along with internal audits to prepare the clients\u2019 employees and site for FDA re-inspection. The expertise, coaching, and guidance Oxford provided for our client is invaluable to their successful re-inspection and future compliance standing with the FDA.<\/p>\n

Partner with us to help you with your remediation projects.<\/p>\n

\n

CONNECT WITH OXFORD \u2192<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Discover how remediation support for a global pharma and healthcare company led to heightened compliance and effective deviation management.<\/p>\n","protected":false},"author":22,"featured_media":40180,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[181],"tags":[113],"category-tag":[],"class_list":["post-40161","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-life-sciences"],"yoast_head":"\nRemediation Support for Multinational Pharma Company - Oxford Global Resources<\/title>\n<meta name=\"description\" content=\"Discover how remediation support for a global pharma and healthcare company led to heightened compliance and effective deviation management.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Remediation Support for Multinational Pharma Company\" \/>\n<meta property=\"og:description\" content=\"Discover how remediation support for a global pharma and healthcare company led to heightened compliance and effective deviation management.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\" \/>\n<meta property=\"og:site_name\" content=\"Oxford Global Resources\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-21T20:23:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-21T20:24:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2025\/05\/GettyImages-1465073079-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1920\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"kcompton\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Geschreven door\" \/>\n\t<meta name=\"twitter:data1\" content=\"kcompton\" \/>\n\t<meta name=\"twitter:label2\" content=\"Geschatte leestijd\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\"},\"author\":{\"name\":\"kcompton\",\"@id\":\"https:\/\/www.oxfordcorp.com\/de\/#\/schema\/person\/42927b5e78a84b0692a4221cdc55bad5\"},\"headline\":\"Remediation Support for Multinational Pharma Company\",\"datePublished\":\"2025-05-21T20:23:07+00:00\",\"dateModified\":\"2025-05-21T20:24:07+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\"},\"wordCount\":362,\"image\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2025\/05\/GettyImages-1465073079-1.jpg\",\"keywords\":[\"Life Sciences\"],\"articleSection\":[\"Case Study\"],\"inLanguage\":\"nl-BE\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\",\"url\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/remediation-support-for-multinational-pharma-company\/\",\"name\":\"Remediation Support for Multinational Pharma Company - 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