In today's ever-changing landscape of technology, there are many new considerations for computer system validation (CSV) to ensure the nuances of each innovative component. For example, we now have more FDA-regulated companies starting to use cloud services and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), Software-as-a-Medical-Device (SaaMD), and the use of mobile devices.
We're seeing companies starting to move, as well, to an agile vs. waterfall approach for development and testing, and in some cases, they are using automated testing.
In addition, the FDA is encouraging companies to follow the principles of Computer Software Assurance (CSA) vs. the traditional CSV. There is a need to apply critical thinking and a discovery mindset as we do the validation activities. This means treating each requirement based on potential risk if it were to fail and doing testing for it accordingly.
In this webinar, we will review the current trends, including in technology and FDA compliance and enforcement. We'll look at Data Integrity, 21 CFR Part 11 (Electronic Records/Electronic Signatures), European Union (EU) Annex 11, General Data Protection Regulation (GDPR), and other regulatory requirements.
We'll walk through the validation process and provide a review of the potential pitfalls as well as best industry practices. This class will also cover the requirements for maintaining a computer system regulated by FDA in a validated state throughout its life cycle.
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.). Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.
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.). Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.
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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