How much does Risk-Based Excel Spreadsheet Validation cost?

Registration options: Recording – 1 Viewer: $450; Recording – Unlimited Viewers: $1500.

Do I receive a certificate after completing Risk-Based Excel Spreadsheet Validation?

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

Home/Catalog/Risk-Based Excel Spreadsheet Validation

Recorded WebinarNew

Risk-Based Excel Spreadsheet Validation

Apply SDLC, GAMP 5, and risk-based validation to Excel spreadsheets used in FDA-regulated activities — covering Part 11, data integrity, and inspection preparation.

4.8(0 reviews)

1.5 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Quantity

Recording – 1 Viewer

$450.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

Identifying when Excel spreadsheets become GxP systems requiring validation

CSV vs. CSA — choosing the right validation approach for spreadsheets

Applying the SDLC to spreadsheet design and testing

Documentation essentials — requirements, testing, and maintenance

Ensuring data integrity and Part 11 compliance in Excel

Conducting a practical, risk-based assessment for spreadsheet validation

About This Event

Discover the strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities. This webinar assesses the potential risks associated with spreadsheet failures on data integrity, process quality, and safety, and explores the System Development Life Cycle (SDLC) validation approach. Excel is categorized as a GAMP 5 Category 1 system during installation, but once macros or custom functionalities are added, it becomes a GAMP 5 Category 5 system, necessitating validation. This course details the planning and validation activities required for custom Excel applications while covering 21 CFR Part 11 compliance and data integrity best practices. Code: FDB3644

Curriculum

When Excel Becomes a GxP System — GAMP 5 Category Identification

12 min

CSV vs. CSA — Choosing the Right Validation Approach

12 min

Applying the SDLC to Spreadsheet Design and Testing

12 min

Requirements

IT analysts, QC/QA managers, lab managers, and business stakeholders using GxP spreadsheets
Applicable to compliance managers, auditors, regulatory affairs personnel, and consultants

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

Excel Spreadsheet Validation GAMP 5 21 CFR Part 11 Data Integrity GxP SDLC CSV

Related Events

AI in GMP: What the FDA Is Already Expecting - Before You Ask

Live WebinarNew-24%

Regulatory & ComplianceCertificate

AI in GMP: What the FDA Is Already Expecting - Before You Ask

FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.