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UID:c5af7024e18d39e59a701f55522471ef@mivado.com
SUMMARY:How to Maximize Quality and Compliance with Advanced CSV/CSA Strate
 gies in 2 days?
DESCRIPTION:Mivado GlobalPerformance CSV/CSA Mastery Training equips biopha
 rma professionals with practical skills to implement risk-based validation 
 and assurance for GxP systems\, blending traditional CSV rigor with modern 
 CSA efficiency.\nThis intensive two-day program delivers hands-on training 
 on combining Computer System Validation (CSV) and Computer Software Assuran
 ce (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\,  LIMS\, QMS\, MES\, and
  clinical systems\, learning to apply GAMP 5 lifecycle principles with CSA
 ’s critical-thinking\, risk-proportionate approach.\nObjectives\nThis tra
 ining transforms theoretical CSV/CSA knowledge into actionable skills\, ena
 bling teams to deliver compliant systems faster while building internal cap
 ability for sustainable compliance. Key objectives of this program are:\n\n
 Master the hybrid CSV/CSA approach to reduce validation effort while mainta
 ining compliance across system lifecycles.\nLearn to classify system functi
 ons by risk and select appropriate assurance activities (scripted testing v
 s. unscripted procedures vs. vendor reliance).\nBuild and document risk-bas
 ed validation strategies\, plans\, and reports that satisfy 21 CFR Part 11\
 , EU Annex 11\, and FDA CSA guidance.\nGain confidence preparing for and re
 sponding to regulatory inspections focused on computerized systems.\n\nKey 
 Learning Areas\nDay 1: Foundations and Planning\n\nRegulatory landscape: GA
 MP 5\, CSV\, CSA\, Part 11/Annex 11 requirements\, and FDA 2025 guidance.\n
 Risk classification: GxP impact assessment\, function-level risk categoriza
 tion\, data integrity focus.\nHybrid lifecycle planning: CSV structure with
  CSA scaling (validation plans\, URS development\, risk assessments).\n\nDa
 y 2: Execution\, Documentation\, and Sustainability\n\nAssurance activities
  by risk tier: scripted IQ/OQ/PQ\, exploratory testing\, vendor package eva
 luation.\nDocumentation strategies: streamlined records\, traceability matr
 ices\, and validation summary reports.\nOperational phase: change control\,
  periodic review\, and decommissioning with CSA principles.\nInspection rea
 diness: mock audit scenarios\, SME coaching\, evidence mapping.\n\nTarget A
 ttendees\n\nQuality Assurance and Compliance professionals managing GxP sys
 tems.\nIT/Validation teams are responsible for system implementation and li
 fecycle management.\nSystem owners and business SMEs (lab\, manufacturing\,
  clinical\, pharmacovigilance).\nRegulatory Affairs staff are preparing for
  computerized systems inspections.\nProject managers oversee validation ini
 tiatives.\n\nTraining Format and Duration\n\n2 full days (7 hours/day): int
 eractive workshops\, case studies\, group exercises\, and mock inspections.
 \nDelivery: in-person or virtual with digital workbooks\, templates\, and a
  post-training resource portal.\nMax 16 participants for optimal interactio
 n and hands-on practice.\n\nKey Takeaways\nParticipants leave with:\n\nComp
 leted risk-based validation plan for a sample GxP system from their organiz
 ation.\nReady-to-use CSV/CSA toolkit: simplified templates (URS\, risk asse
 ssment\, test strategy\, summary report).\nConfidence classifying system fu
 nctions and selecting proportionate assurance activities.\nPractical inspec
 tion skills: how to walk regulators through validation evidence and respond
  to findings.\nDigital reference materials and 30-day post-training Q&A sup
 port from Mivado GlobalPerformance experts.\n\nMore information could be fo
 und here: CSV-CSA: Implying a smart\, analytical approach to software assur
 ance\nSpeaker\nKossi Molley\, Chimiste\, LSSBB\, PMP
LOCATION:Online
DTSTAMP:20260726T014829Z
DTSTART:20260805T130000Z
DTEND:20260806T200000Z
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