The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

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.

• Apply best practices so all systems are validated appropriately
• Develop a validation strategy that balances cost and risk
• Plan validation projects to save time and reuse past work
• Test efficiently so deficiencies are found before go-live
• Document validation work and keep system records current
• Maintain systems in a validated state as changes occur
• Avoid key pitfalls when applying the SDLC methodology

• Computer system validation (CSV)
• System Development Life Cycle (SDLC) methodology and its phases
• Validation planning
• Risk assessment
• GAMP 5 system categorization
• Functional requirements
• IQ, OQ and PQ testing
• User acceptance
• Maintaining a system in a validated state
• Policies and procedures
• Training
• Organizational readiness and managing change
• Optimizing business processes during implementation
• Documentation
• Common pitfalls, 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.

• Information Technology (IT) analysts
• IT developers
• IT support staff
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers and auditors
• Lab managers and analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders using computer systems regulated by FDA
• Regulatory Affairs personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns working at the companies listed above
• College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

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 project management instructor for non-profit organizations.