FDA Compliance And Laboratory Computer System Validation

Laboratory computer system validation is critical for any FDA-regulated organization, but the volume of guidance can be overwhelming. This 90-minute webinar condenses decades of industry best practice into the methods, techniques and tools that give compliant results at the lowest cost.

Using the System Development Life Cycle (SDLC) framework, you'll learn how to plan, execute and manage validation of laboratory systems, and how GAMP 5 categories shape the validation approach, especially testing. You'll review the key documentation needed to validate systems and keep them in a validated state.

The session also covers building a standardized program across all FDA-regulated systems, training for business and IT staff, business process re-engineering opportunities when replacing legacy systems, and why formal organizational change management helps users adopt new technology.

• Understand FDA requirements for laboratory computer system validation (CSV)
• Apply the SDLC approach to validating laboratory systems
• Use GAMP 5 classification and risk methods to set a validation pathway
• Build a complete validation strategy, program and FDA-compliant documentation
• Monitor production systems and govern data through to retirement
• Maintain the policies and procedures that support systems in operation
• Use vendors and external resources to apply best practices and avoid pitfalls
• Keep up with FDA trends in oversight and audit of laboratory systems

• Laboratory computer system validation planning, execution and management
• Best practices for compliant results at minimum cost
• Identifying the system's GAMP 5 category to guide validation and testing
• Key documentation for validating laboratory systems and keeping them validated
• Creating a standardized program across FDA-regulated systems
• Training for business and IT staff involved in validation
• Business process re-engineering opportunities when implementing a new system
• Using formal organizational change management to support user adoption
• Q&A

Best practices developed over the past 30 years can make laboratory system validation efficient and compliant, if you know which ones matter most. This course points you to the most critical and cost-effective approaches.

It suits IT analysts, developers and testers, QC/QA staff, analytical chemists, lab, compliance and audit managers, automation analysts, CSV and GMP training specialists, business stakeholders and life sciences consultants who plan, run, manage or support FDA-regulated systems.

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

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.