Faculty: Carolyn Troiano | Code: SEM13451
This 3-Hour course clarifies how to classify cloud systems with precision, using CSA thinking to prevent wasted effort and hidden compliance risks. It strengthens judgment so teams validate what matters and avoid the traps that undermine inspection readiness.
Classification mistakes are one of the biggest reasons cloud validation efforts fall apart. Teams often rely on legacy CSV thinking when systems demand sharper, risk-driven judgment. Digital Validation and Cloud Assurance helps teams assess intended use, GxP relevance, and critical workflows without drowning in unnecessary documentation. Misreading complexity or misunderstanding shared responsibility leads to weak audit defenses and data integrity gaps. By anchoring early decisions in Computer Software Assurance principles and risk-based validation, companies can avoid costly missteps. Digital Validation and Cloud Assurance provides a clear, modern way to classify cloud systems before validation begins — and sets the tone for everything that follows.
This is Module 1 of Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA".
You can either sign up only for this Module here.
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.