CSV: GxP Compliance, Cloud, AI and Continuous Validation
End-to-end Computerized System Validation—from GAMP 5 and risk-based validation to cloud, AI, go-live and continuous compliance.
This three-day program equips pharmaceutical, biotechnology and life-sciences professionals with the knowledge, frameworks and practical tools required to execute, document and manage Computerized System Validation in GxP-regulated environments. It covers the complete CSV lifecycle—from system categorisation, URS and risk assessment through IQ, OQ, PQ, go-live and periodic review—while addressing 21 CFR Part 11, EU Annex 11, GAMP 5, cloud, SaaS, AI/ML and Agile validation. Practitioner cases, template walkthroughs and validation exercises connect regulatory expectations with real project execution.
Who Should Attend
- Validation Engineers and CSV Consultants
- QA, Compliance and Regulatory Affairs professionals
- IT Project Managers, System Owners and Business Analysts
- Clinical, Pharmacovigilance, LIMS, CTMS and Veeva System Owners
- IT Infrastructure, Cloud and Digital Transformation teams
Business Outcomes
- Develop inspection-ready CSV strategies aligned with GAMP 5 and GxP requirements.
- Apply risk-based validation without creating compliance gaps or over-validation.
- Produce traceable lifecycle documentation from URS through PQ and system release.
- Validate SaaS, cloud and AI-enabled systems using appropriate modern approaches.
- Sustain the validated state through change control, periodic review and continuous monitoring.
Course Content
Foundations of CSV and the Regulatory Landscape
Documentation, Risk and Compliance Practice
Advanced CSV, Cloud, AI and Go-Live
Meet Your Instructor
Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!
₹240,000
This course includes:
- Lessons 14
- Topics 71
- Duration 3 Days
- Quizzes 0
- Language English
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