Overview:
In
2025, the FDA's expectations for validated computer systems have never been
higher—or more closely watched. Whether you’re in pharmaceuticals, biotech,
medical devices, or clinical research, if your systems support GxP
activities—like production, quality management, lab data handling, or clinical
trial operations—then you can expect them to be audited and inspected. And when
the FDA walks through your doors, they’ll be looking for more than just a
validation plan—they’ll expect to see complete, risk-based, real-world evidence
that your system works as intended, protects data integrity, and complies with
regulatory standards.
This
session is designed to help you get there. We’ll walk you through exactly what
the FDA wants to see during a computer system inspection, how those
expectations have changed in recent years, and what audit-readiness really
looks like in today’s landscape. Whether your audit is internal, driven by a
third party, or part of an official FDA inspection, the preparation approach
must be the same: proactive, structured, and risk-informed.
We’ll
begin by examining the current state of Computer System Validation (CSV)—the
traditional, documentation-driven approach—and why it’s still a cornerstone of
compliance. But we’ll also explore how new technologies, evolving software
development practices, and the rise of cloud-based platforms have made it more
difficult to apply CSV in a one-size-fits-all way. That’s where the FDA’s draft
guidance on Computer Software Assurance (CSA), released in September 2022,
comes into play.
CSA
offers a more flexible, modern validation approach that prioritizes critical
thinking, system risk, and intended use over exhaustive documentation. While
it’s still in draft form as of mid‑2025, many
companies are already using CSA principles to streamline validation
efforts—especially when it comes to production and quality system software.
We’ll also tie in GAMP®5, 2nd Edition, which provides a practical framework for
applying CSA and supports both Agile and Waterfall development methodologies.
But
understanding CSA and CSV is only part of the story. To be fully audit- and
inspection-ready, you also need to anticipate how the FDA will evaluate your
systems in practice. That means understanding their inspection process, knowing
what triggers their attention, and preparing the right documentation and
controls in advance. We’ll cover real-world FDA findings and recent enforcement
trends, showing where companies often fall short—and how you can avoid those
same pitfalls.
We’ll
also discuss data integrity in depth, including how the FDA continues to
enforce the ALCOA+ principles: making sure your data is attributable, legible,
contemporaneous, original, accurate, complete, consistent, enduring, and
available. If your systems involve third-party vendors, SaaS platforms, or
cloud services, you’ll learn how to maintain oversight and ensure your
validation, access control, and archival practices are defensible during an
inspection.
Throughout
the session, we’ll bring the theory into real-world focus: how to plan,
document, and rehearse for an FDA system audit; how to structure your risk
assessments; how to organize your audit room and inspection day logistics; and
how to prepare your team to respond confidently to investigator questions.
Whether
you’re building your validation strategy from scratch or looking to upgrade
existing systems to align with FDA expectations, this webinar will give you the
clarity, tools, and forward-looking insight needed to navigate your next audit
or inspection with confidence—and come out ahead.
Areas
covered during the session:
- Computer
System Validation (CSV) and the System Development Life Cycle (SDLC)
Methodology
- Computer
Software Assurance (CSA), Draft Guidance from FDA issued September 2022
- GAMP®5,
2nd Edition, published by ISPE in July 2022, and alignment with CSA
- Waterfall
and Agile, as Software Development, Testing, and Release Life Cycle
Methodologies
- “GxP”
– Good Manufacturing, Laboratory and Clinical Practices
- 21
CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Data
Integrity and the “ALCOA+” Principles (attributable, legible, contemporaneous,
original or “true copy,” accurate, complete, consistent, enduring, and
available)
- Data
Archival and Governance to ensure security, integrity and compliance
- Validation
Strategy that will take into account the system risk assessment and system
categorization (GAMP®5) processes
- Recent
FDA findings and citations for companies in regulated industries
- The
resources, documentation and room preparation necessary to adequately prepare
for FDA inspection
- Q&A
Handouts
included:
Attendees
will receive two exclusive downloadable handouts, including:
- FDA
Computer System Inspection Preparation Checklist
- CSV
vs. CSA Comparison Quick Reference Guide
Why Should
You Attend?
If
your company relies on computer systems to support GxP activities, you’re
already operating in a high-risk compliance environment. FDA inspections can
happen with little notice, and when they do, your validation practices,
documentation, and system controls will be under the microscope. This webinar
will help you understand what the FDA looks for—so you’re not scrambling to
respond when that day comes.
You’ll
gain clarity on the difference between traditional CSV and the newer CSA
approach, and learn how to apply the right validation strategy based on your
system’s risk, function, and regulatory exposure. Whether you're overseeing a
cloud-based platform, legacy infrastructure, or a newly developed software
solution, you'll leave with practical methods for preparing your systems for
scrutiny.
Most
importantly, this session will walk you through what real inspection readiness
looks like—how to plan, what to document, how to communicate, and how to ensure
your systems, your team, and your records all stand up to FDA expectations.
What
industries will benefit from your training:
Manufacturing,
Testing, Packaging and Distribution companies in the following industries that
are regulated by FDA are required to follow GxPs:
- Pharmaceutical
(for drug products introduced using a medical device)
- Medical
Device
- Biologicals
(for biological products introduced using a medical device)
- Tobacco
(based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor
(based on the “Deeming” Act of 2016)
- E-Cigarette
(based on the “Deeming” Act of 2016)
- Cigar
(based on the “Deeming” Act of 2016)
- Third-Party
companies that support those in the above industries, including Contract
Research Organizations (CROs)
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
Who
Will Benefit?
- Information
Technology Analysts
- QC/QA
Managers
- QC/QA
Analysts
- Clinical
Data Managers
- Clinical
Data Scientists
- Analytical
Chemists
- Compliance
Managers
- Laboratory
Managers
- Automation
Analysts
- Manufacturing
Managers
- Manufacturing
Supervisors
- Supply
Chain Specialists
- Computer
System Validation Specialists
- GMP
Training Specialists
- Business
Stakeholders responsible for computer system validation planning, execution,
reporting, compliance, maintenance and audit
- Consultants
working in the life sciences industry who are involved in computer system
implementation, validation and compliance
- Auditors
engaged in the internal inspection of labeling records and practices
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Enrollment Options
Tags: FDA webinar, CSV webinar, CSA 2025, FDA computer system audit, GAMP5 training, ALCOA+ compliance, FDA inspection checklist, SaaS validation, cloud system compliance, FDA audit readiness, Carolyn, Troiano, July 2025, Webinar