FDA Compliance and GAMP V Computer System Classification

You should attend this seminar 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.

We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP5. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.

Areas Covered in the Session : 

• Gain an understanding of GAMP V computer system classifications
• Develop the ability to apply GAMP V in classifying computer systems in your organization
• Understand the level of computer system validation required, based on the classification as determined using GAMP V
• Discuss the best practices necessary to ensure all systems are classified properly and validated appropriately
• Learn how to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP V
• Understand how to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validated
• Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
• Understand the level of training required for the various GAMP V computer system classifications, and the skills and expertise necessary to make the classification determination
• Industry Best Practices

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.

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• 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

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.