How to Maximize Quality and Compliance with Advanced CSV/CSA Strategies in 2 days?

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.

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,  LIMS, QMS, MES, and clinical systems, learning to apply GAMP 5 lifecycle principles with CSA’s critical-thinking, risk-proportionate approach.

Objectives

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:

• Master the hybrid CSV/CSA approach to reduce validation effort while maintaining compliance across system lifecycles.
• Learn to classify system functions by risk and select appropriate assurance activities (scripted testing vs. unscripted procedures vs. vendor reliance).
• Build and document risk-based validation strategies, plans, and reports that satisfy 21 CFR Part 11, EU Annex 11, and FDA CSA guidance.
• Gain confidence preparing for and responding to regulatory inspections focused on computerized systems.

Key Learning Areas

Day 1: Foundations and Planning

• Regulatory landscape: GAMP 5, CSV, CSA, Part 11/Annex 11 requirements, and FDA 2025 guidance.
• Risk classification: GxP impact assessment, function-level risk categorization, data integrity focus.
• Hybrid lifecycle planning: CSV structure with CSA scaling (validation plans, URS development, risk assessments).

Day 2: Execution, Documentation, and Sustainability

• Assurance activities by risk tier: scripted IQ/OQ/PQ, exploratory testing, vendor package evaluation.
• Documentation strategies: streamlined records, traceability matrices, and validation summary reports.
• Operational phase: change control, periodic review, and decommissioning with CSA principles.
• Inspection readiness: mock audit scenarios, SME coaching, evidence mapping.

Target Attendees

• Quality Assurance and Compliance professionals managing GxP systems.
• IT/Validation teams are responsible for system implementation and lifecycle management.
• System owners and business SMEs (lab, manufacturing, clinical, pharmacovigilance).
• Regulatory Affairs staff are preparing for computerized systems inspections.
• Project managers oversee validation initiatives.

Training Format and Duration

• 2 full days (7 hours/day): interactive workshops, case studies, group exercises, and mock inspections.
• Delivery: in-person or virtual with digital workbooks, templates, and a post-training resource portal.
• Max 16 participants for optimal interaction and hands-on practice.

Key Takeaways

Participants leave with:

• Completed risk-based validation plan for a sample GxP system from their organization.
• Ready-to-use CSV/CSA toolkit: simplified templates (URS, risk assessment, test strategy, summary report).
• Confidence classifying system functions and selecting proportionate assurance activities.
• Practical inspection skills: how to walk regulators through validation evidence and respond to findings.
• Digital reference materials and 30-day post-training Q&A support from Mivado GlobalPerformance experts.

More information could be found here: CSV-CSA: Implying a smart, analytical approach to software assurance

Speaker

Kossi Molley, Chimiste, LSSBB, PMP