Validating a computer system subject to FDA regulations means proving it does what it is supposed to do and keeping it in a validated state from conception to retirement. This 90-minute computer system validation (CSV) webinar shows how to do that step by step using the System Development Life Cycle (SDLC) methodology.
You'll see how the SDLC phases form the basis of every CSV project and why the order of steps matters. Topics include validation planning, risk assessment, GAMP 5 system categories, functional requirements, IQ, OQ and PQ testing, and user acceptance.
The session also covers policies and procedures, training, organizational readiness, documentation, and common pitfalls illustrated with real industry examples.
Good planning cuts the time and labor of validation, reuses past work and catches deficiencies before go-live. Strong change control and documentation keep a system validated without a full revalidation later.
This session suits IT analysts, developers and support staff, QA/QC managers, clinical data and lab staff, compliance managers and auditors, validation and GMP training specialists, regulatory affairs staff, consultants and students studying FDA compliance.
Good planning cuts the time and labor of validation, reuses past work and catches deficiencies before go-live. Strong change control and documentation keep a system validated without a full revalidation later.
This session suits IT analysts, developers and support staff, QA/QC managers, clinical data and lab staff, compliance managers and auditors, validation and GMP training specialists, regulatory affairs staff, consultants and students studying FDA compliance.
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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