Risk-based Excel Spreadsheet Validation - 2026 Updates
Master risk-based Excel spreadsheet validation for FDA-regulated environments — covering GAMP 5, SDLC, 21 CFR Part 11, data integrity, and inspection readiness.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
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What You'll Learn
About the event
About this event
Discover the strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities. We'll assess the potential risks associated with spreadsheet failures on data integrity, process quality, and safety. Explore the System Development Life Cycle (SDLC) validation approach, emphasizing risk assessment, and delve into the significance of managing electronic records and signatures according to 21 CFR Part 11.
Our webinar will guide you through the validation process for Excel spreadsheets used in FDA-regulated tasks. Excel, categorized as a GAMP 5 Category 1 system during installation, must be handled with precision. However, once macros or custom functionalities are added, it becomes a GAMP 5 Category 5 system, necessitating validation to ensure accurate coding.
We'll detail the planning and validation activities required for custom Excel applications. While full validation, including Installation Qualification (IQ) and Operational Qualification (OQ), is essential, we'll streamline the process. Learn how to define and test requirements, incorporate system suitability with input from Subject Matter Experts (SMEs), and ensure compliance with FDA validation, Part 11, and data integrity requirements.
Explore the creation of essential policies, procedures, and supporting documentation for spreadsheet compliance. Maintain your validated spreadsheet application effectively and prepare for FDA inspections with our insights.
Code: FDB3644
Curriculum
Requirements
- IT, QA, QC, or validation professionals in FDA-regulated industries working with Excel-based tools
- Applicable to computer system validation specialists, compliance managers, lab managers, and business stakeholders using GxP spreadsheets
Who Should Attend
Information Technology (IT) Analysts, IT Developers, IT Support Staff, QC/QA Managers and Analysts, Production Managers and Supervisors, Clinical Data Managers and Scientists, Compliance Managers and Auditors, Lab Managers and Analysts, Computer System Validation Specialists, GMP/GLP/GCP Training Specialists, Business Stakeholders using Computer Systems regulated by FDA, Regulatory Affairs Personnel, Consultants in the Life Sciences and Tobacco Industries.
Areas Covered
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.
This webinar has ended
The recording is available to purchase.
Recording – 1 Viewer
On-demand recording access for 1 viewer
$450.00
Recording – Unlimited Viewers
On-demand recording access for unlimited viewers
$1,500.00
Event Details
Format
Live Webinar
Duration
90 minutes
Certificate
Included
Date
Friday, September 25, 2026
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