The Smart Way to Classify Cloud GxP Systems Before You Validate — 3-Hour Course
A 3-hour course on classifying cloud GxP systems with precision using CSA — assess intended use, GxP relevance, risk, and shared responsibility before validation begins.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
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. This 3-Hour course 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, companies can avoid costly missteps and set the tone for everything that follows.
This is Module 1 of the Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA."
Code: SEM13451
Curriculum
Requirements
- QA, QC, Regulatory Affairs, Validation, IT, and Cloud Engineering professionals
- Applicable to manufacturing leadership, R&D, and compliance teams working with cloud systems
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
3 hours
Certificate
Included
Access
Lifetime
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