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CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

Break through CSV conditioning — learn how to build FDA-defensible evidence using CSA, size effort with risk-based thinking, and align with GAMP 5 (2nd Edition) without the paperwork burden.

4.9(0 reviews)

1.5 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

CSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See

Quantity

Recording – 1 Viewer

$450.00

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Secure payment via Stripe

Certificate of completion

What You'll Learn

Understanding GxP systems and intended use in the CSA framework

CSV vs. CSA — what actually changes in evidence and documentation

Risk assessment for CSA: sizing the effort correctly

Writing requirements and tests that support assurance (not just paperwork)

Documentation that proves control without excess burden

Essential data integrity (ALCOA+++) and Part 11 controls for CSA packages

About This Event

Modern life-sciences teams are under increasing pressure to deliver systems that work, withstand scrutiny, and don't drown projects in unnecessary documentation. That's exactly where Computer Software Assurance (CSA) changes the game — and where most companies still get it wrong. This 90-minute session breaks through the noise and shows you how to build evidence the FDA actually wants to see, not the paperwork we've been conditioned to generate. You'll understand how intended use drives everything, where traditional CSV thinking quietly sabotages speed, and how CSA gives you the freedom to focus on what truly matters: proving your system is fit for its purpose. Code: FDB1344

Curriculum

GxP Systems, Intended Use, and What CSV vs. CSA Actually Changes

15 min

Risk Assessment for CSA — Sizing the Effort Correctly

12 min

Writing Requirements and Tests That Support Assurance

12 min

Requirements

IT analysts, QA/QC managers, compliance auditors, and regulatory affairs specialists
Applicable to CSV specialists, lab managers, business stakeholders, and clinical data managers

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

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

1.5 hours

Certificate

Included

Access

Lifetime

Topics

CSA CSV FDA GAMP 5 Validation Data Integrity ALCOA+GxP Inspection Readiness

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