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Recorded WebinarNew

How to Validate Automated Pipelines Under CSA — 3-Hour Course

A 3-hour course on validating CI/CD pipelines and automated workflows under CSA — challenge-based testing, automated evidence, and maintaining audit readiness in rapid-release environments.

4.8(0 reviews)
3 hours
Carolyn Troiano

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

What You'll Learn

Why automated pipelines break traditional CSV approaches
Validating CI/CD, DevOps, and rapid-release systems under CSA
Challenge-based testing under CSA and automated test evidence
Bots, scripts, and AI-assisted validation considerations
AI/ML model drift expectations and impact analysis for constant updates
Integrations, APIs, and data movement integrity in automated environments

About This Event

Automated pipelines introduce speed, volume, and change rates that overwhelm traditional validation approaches. This 3-Hour course teaches teams 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. This course provides an achievable assurance model that supports rapid development without weakening audit readiness. This is Module 3 of the Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA." Code: SEM13453

Curriculum

Why Automated Pipelines Break Traditional CSV
20 min
Validating CI/CD, DevOps, and Rapid-Release Systems
20 min
Challenge-Based Testing and Automated Test Evidence
20 min

Requirements

  • QA, Validation, IT, Cloud Engineering, and Automation professionals
  • Applicable to R&D, digital development, lab informatics, and compliance teams

Meet Your Instructor

Carolyn Troiano

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
1

Recording – 1 Viewer

$498.00
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Certificate of completion

Event Details

Format

Recorded Webinar

Duration

3 hours

Certificate

Included

Access

Lifetime

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