FDA continues to focus heavily on data integrity during inspections, and validation of regulated computer systems has to show clearly that each system does what it is meant to do. This 60-minute webinar on FDA data integrity guidance for regulated computer systems explains how to get there.
FDA's computerized systems guidelines date to 1983, and apart from technology, little about validation has changed. You'll learn to write unique, testable functional requirements and test scripts, set the level of testing from a risk assessment of likelihood, severity and detectability of failure, and use GAMP 5 categorization to justify it in the validation plan.
The session also covers validation policies and procedures, training, disaster recovery and business continuity, change control, periodic review, and how new technologies can add oversight burden.
The share of Form 483 citations and warning letters involving data integrity rose sharply over a ten-year period, making it a major inspection target. A well-documented, SDLC-based validation that keeps systems in a validated state from conception to retirement helps you withstand FDA scrutiny and protect your data.
This session suits IT, QA/QC, clinical data, compliance, lab and automation staff, CSV and GMP training specialists, business stakeholders and life sciences consultants.
The share of Form 483 citations and warning letters involving data integrity rose sharply over a ten-year period, making it a major inspection target. A well-documented, SDLC-based validation that keeps systems in a validated state from conception to retirement helps you withstand FDA scrutiny and protect your data.
This session suits IT, QA/QC, clinical data, compliance, lab and automation staff, CSV and GMP training specialists, business stakeholders and life sciences consultants.
Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a …
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