FDA Compliance and Laboratory Computer System Validation

You should attend this seminar if you are 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.

Areas Covered in the Session : 

• Gain an understanding of laboratory system computer validation planning, execution and management concepts
• Discuss the 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

Who Should Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are 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. Professionals who will benefit include:

• 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.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.