{"id":6345,"date":"2026-03-07T23:27:01","date_gmt":"2026-03-08T04:27:01","guid":{"rendered":"https:\/\/mivado.com\/eshop\/?post_type=etn&#038;p=6345"},"modified":"2026-05-23T20:16:21","modified_gmt":"2026-05-24T00:16:21","slug":"how-to-maximize-quality-and-compliance-with-advanced-csv-csa-strategies-in-2-days","status":"publish","type":"etn","link":"https:\/\/mivado.com\/eshop\/m_event\/how-to-maximize-quality-and-compliance-with-advanced-csv-csa-strategies-in-2-days\/","title":{"rendered":"How to Maximize Quality and Compliance with Advanced CSV\/CSA Strategies in 2 days?"},"content":{"rendered":"<h3>Mivado GlobalPerformance CSV\/CSA Mastery Training equips biopharma professionals with practical skills to implement risk-based validation and assurance for GxP systems, blending traditional CSV rigor with modern CSA efficiency.<\/h3>\n<p>This intensive two-day program delivers hands-on training on combining Computer System Validation (CSV) and Computer Software Assurance (CSA) to validate GxP computerized systems efficiently while meeting FDA, EMA, and global regulatory expectations. Participants work through real-world biopharma scenarios covering Cloud System,\u00a0 LIMS, QMS, MES, and clinical systems, learning to apply GAMP 5 lifecycle principles with CSA\u2019s critical-thinking, risk-proportionate approach.<\/p>\n<h2>Objectives<\/h2>\n<p>This training transforms theoretical CSV\/CSA knowledge into actionable skills, enabling teams to deliver compliant systems faster while building internal capability for sustainable compliance. Key objectives of this program are:<\/p>\n<ul>\n<li>Master the hybrid CSV\/CSA approach to reduce validation effort while maintaining compliance across system lifecycles.<\/li>\n<li>Learn to classify system functions by risk and select appropriate assurance activities (scripted testing vs. unscripted procedures vs. vendor reliance).<\/li>\n<li>Build and document risk-based validation strategies, plans, and reports that satisfy 21 CFR Part 11, EU Annex 11, and FDA CSA guidance.<\/li>\n<li>Gain confidence preparing for and responding to regulatory inspections focused on computerized systems.<\/li>\n<\/ul>\n<h2>Key Learning Areas<\/h2>\n<p><strong>Day 1: Foundations and Planning<\/strong><\/p>\n<ul>\n<li>Regulatory landscape: GAMP 5, CSV, CSA, Part 11\/Annex 11 requirements, and FDA 2025 guidance.<\/li>\n<li>Risk classification: GxP impact assessment, function-level risk categorization, data integrity focus.<\/li>\n<li>Hybrid lifecycle planning: CSV structure with CSA scaling (validation plans, URS development, risk assessments).<\/li>\n<\/ul>\n<p><strong>Day 2: Execution, Documentation, and Sustainability<\/strong><\/p>\n<ul>\n<li>Assurance activities by risk tier: scripted IQ\/OQ\/PQ, exploratory testing, vendor package evaluation.<\/li>\n<li>Documentation strategies: streamlined records, traceability matrices, and validation summary reports.<\/li>\n<li>Operational phase: change control, periodic review, and decommissioning with CSA principles.<\/li>\n<li>Inspection readiness: mock audit scenarios, SME coaching, evidence mapping.<\/li>\n<\/ul>\n<h2>Target Attendees<\/h2>\n<ul>\n<li>Quality Assurance and Compliance professionals managing GxP systems.<\/li>\n<li>IT\/Validation teams are responsible for system implementation and lifecycle management.<\/li>\n<li>System owners and business SMEs (lab, manufacturing, clinical, pharmacovigilance).<\/li>\n<li>Regulatory Affairs staff are preparing for computerized systems inspections.<\/li>\n<li>Project managers oversee validation initiatives.<\/li>\n<\/ul>\n<h2>Training Format and Duration<\/h2>\n<ul>\n<li>2 full days (7 hours\/day): interactive workshops, case studies, group exercises, and mock inspections.<\/li>\n<li>Delivery: in-person or virtual with digital workbooks, templates, and a post-training resource portal.<\/li>\n<li>Max 16 participants for optimal interaction and hands-on practice.<\/li>\n<\/ul>\n<h2>Key Takeaways<\/h2>\n<p>Participants leave with:<\/p>\n<ul>\n<li>Completed risk-based validation plan for a sample GxP system from their organization.<\/li>\n<li>Ready-to-use CSV\/CSA toolkit: simplified templates (URS, risk assessment, test strategy, summary report).<\/li>\n<li>Confidence classifying system functions and selecting proportionate assurance activities.<\/li>\n<li>Practical inspection skills: how to walk regulators through validation evidence and respond to findings.<\/li>\n<li>Digital reference materials and 30-day post-training Q&#038;A support from Mivado GlobalPerformance experts.<\/li>\n<\/ul>\n<p>More information could be found here: <a href=\"https:\/\/mivado.com\/mgp\/services\/computer-system-validation\/\" target=\"_blank\" rel=\"noopener\">CSV-CSA: Implying a smart, analytical approach to software assurance<\/a><\/p>\n<h2>Speaker<\/h2>\n<p><a href=\"https:\/\/ca.linkedin.com\/in\/kossi-molley-3534923\" target=\"_blank\" rel=\"noopener\">Kossi Molley, Chimiste, LSSBB, PMP<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mivado GlobalPerformance CSV\/CSA Mastery Training equips biopharma professionals with practical skills to implement risk-based validation and assurance for GxP systems, blending traditional CSV rigor with modern CSA efficiency.<\/p>\n","protected":false},"author":2,"featured_media":6279,"parent":0,"template":"","etn_category":[25,199],"etn_tags":[206,29,33,37,202],"class_list":["post-6345","etn","type-etn","status-publish","has-post-thumbnail","hentry","etn_category-english","etn_category-masterclass","etn_tags-computerized-system-validation","etn_tags-csa-csa","etn_tags-laboratory","etn_tags-quality","etn_tags-quality-control"],"tutor_lms_mapping":{},"_links":{"self":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn\/6345","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn"}],"about":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/types\/etn"}],"author":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/users\/2"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media\/6279"}],"wp:attachment":[{"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/media?parent=6345"}],"wp:term":[{"taxonomy":"etn_category","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn_category?post=6345"},{"taxonomy":"etn_tags","embeddable":true,"href":"https:\/\/mivado.com\/eshop\/wp-json\/wp\/v2\/etn_tags?post=6345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}