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Computer System Validation (CSV) Implementation Boot Camp: Practical Validation of GxP Computerised Systems (Aug 19th - Aug 21st, 2026)

GlobeNewswire
As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle. As life sciences, pharmaceutical, biotech, and medical device organizations accelerate digital transformation highlighted by the shift toward FDA Computer Software Assurance (CSA) draft guidance, GAMP® 5 (Second Edition) risk-based validation, and cloud/SaaS deployments ensuring 21 CFR Part 11 and EU Annex 11 regulatory compliance remains paramount. This practical training course equips QA/QC professionals, IT system owners, and regulatory auditors with actionable methodologies for modernizing the System Development Life Cycle (SDLC), conducting critical-thinking risk assessments, writing IQ/OQ/PQ test protocols, maintaining data integrity, and establishing audit-ready documentation across the full system lifecycle.
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