We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We will cover the changes and impact on validation as a result. We will also cover FDA’s recent draft guidance on Computer Software Assurance (CSA) and what that means in terms of how to approach validation.
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.
We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance. We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.
Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment, that can be leveraged to assist in all your GxP work.
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).
Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022, and CSA, a new approach that is subject of a Draft guidance from FDA that was issued in September 2022. These two guidances will reshape the way companies handle validation of computer systems that are based on newer and more innovative technologies.
Rather than avoiding these modern breakthroughs in technology and continuing to rely on older ways of conducting business, attendees will learn how to adapt their current practices and thinking about validation to leverage these innovative tools and advance their ability to bring their companies to a new level of success. Newer technologies will help them bring more advanced products to the marketplace and this can be achieved by learning how to approach validation to continue meeting FDA compliance.
This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.).
Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022, and CSA, a new approach that is subject of a Draft guidance from FDA that was issued in September 2022. These two guidances will reshape the way companies handle validation of computer systems that are based on newer and more innovative technologies.
Rather than avoiding these modern breakthroughs in technology and continuing to rely on older ways of conducting business, attendees will learn how to adapt their current practices and thinking about validation to leverage these innovative tools and advance their ability to bring their companies to a new level of success. Newer technologies will help them bring more advanced products to the marketplace and this can be achieved by learning how to approach validation to continue meeting FDA compliance.
Carolyn Troiano
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 …
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