Do I receive a certificate after completing The Smart Way to Classify Cloud GxP Systems Before You Validate — 3-Hour Course?

Yes, a certificate of completion is included with your registration.

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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.

4.8(0 reviews)

3 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

The Smart Way to Classify Cloud GxP Systems Before You Validate — 3-Hour Course

Quantity

Recording – 1 Viewer

$498.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

FDA's shift from CSV to CSA and what it means for classification

Identifying GxP systems in modern digital and cloud environments

Intended use, risk assessment (complexity, criticality, GAMP 5, failure risk)

CSV foundation — requirements, design, testing, and release

Why CSV fails in cloud environments

Data integrity basics (ALCOA++) and introduction to Shared Responsibility

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

FDA's Shift from CSV to CSA — What Changes

20 min

Identifying GxP Systems in Cloud Environments

20 min

Intended Use, Risk, Criticality, and GAMP 5 Classification

20 min

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.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant

Quantity

Recording – 1 Viewer

$498.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

3 hours

Certificate

Included

Access

Lifetime

Topics

CSA Cloud Classification GxP GAMP 5 Risk Assessment CSV Data Integrity ALCOA+

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