FDA Compliance And Laboratory Computer System Validation

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

• Understand FDA requirements for laboratory Computer System Validation (CSV)
• Understand the System Development Life Cycle (SDLC) approach to validation of laboratory systems
• Utilize GAMP 5 system classification and risk methodologies for categorizing laboratory systems and developing a validation pathway
• Understand how to build a complete validation strategy and program for laboratory systems
• Know how to manage the validation process and create FDA-compliant documentation for laboratory systems
• Know how to monitor a laboratory system that is in production, governing the data and system through retirement
• Know the policies and procedures that must be developed and maintained to support the laboratory system in operation
• Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a laboratory system
• Know about FDA trends in oversight and audit of laboratory systems and how to keep abreast of these

• Gain an understanding of laboratory system computer validation planning, execution and management concepts
• Best practices for laboratory computer system validation that will ensure compliant results while minimizing costs
• Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing
• Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs
• Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems
• Understand the training that must be provided to business and IT staff involved in the validation process
• Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality
• Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality
• Q&A

This webinar will benefit those responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available. It will assist those responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.

• 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.