This 3-Hour course teaches teams to validate automated pipelines with confidence - capturing defensible evidence, managing rapid releases, and maintaining audit-ready control in environments where change never stops.
Why This Training Matters
Automated pipelines introduce speed, volume, and change rates that overwhelm traditional validation approaches. Digital Validation and Cloud Assurance shows teams how to validate CI/CD pipelines, integrations, and automated workflows while preserving data integrity and risk-based validation discipline. Without the right controls, automated systems drift, evidence becomes unreliable, and compliance collapses quickly during inspections. Challenge-based testing and automated test evidence are essential, yet many teams lack a structured method. Digital Validation and Cloud Assurance turns these complexities into an achievable assurance model that supports rapid development without weakening audit readiness.Course Content
- Why automated pipelines break CSV
- Validating CI/CD, DevOps, rapid-release systems
- Challenge-based testing under CSA
- Automated test evidence
- Bots, scripts & AI-assisted validation
- AI/ML model drift expectations
- Impact analysis for constant updates
- Integrations + APIs + data movement integrity
Speaker
Carolyn Troiano brings decades of real-world validation leadership across pharma, medical devices, biotech, and other FDA-regulated sectors. She helped shape early CSV approaches, contributed to 21 CFR Part 11 discussions, and has guided global companies through complex system implementations. Her style is practical, clear, and rooted in hands-on experience with modern cloud and CSA expectations.Who Should Attend
- Quality Assurance (QA)
- Quality Control (QC)
- Regulatory Affairs (RA)
- Validation / Computerized System Validation (CSV)
- Information Technology / Information Systems (IT/IS)
- Cloud Engineering and Automation Teams
- Manufacturing and Production Leadership
- Data Governance and Data Integrity Teams
- R&D and Digital Development Teams
- Lab Informatics and LIMS/ELN Administrators
- Compliance, Audit, and Inspection Readiness Teams
- Design and Software Development Engineers
