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.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
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. 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
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.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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