Cloud services, SaaS, IaaS, PaaS, software as a medical device and mobile devices all add new questions to computer system validation (CSV). This 90-minute data integrity and 21 CFR Part 11 webinar reviews current technology trends alongside FDA compliance and enforcement.
You'll see why the FDA encourages Computer Software Assurance (CSA) over traditional CSV, and how critical thinking and risk lead the test effort: each requirement is tested according to the risk if it fails. The session also looks at agile vs waterfall development and automated testing.
The trainer covers data integrity, 21 CFR Part 11 for electronic records and signatures, EU Annex 11, the General Data Protection Regulation (GDPR) and related requirements. You'll walk through the validation process, common pitfalls and industry best practices, and how to keep a regulated system in a validated state across its life cycle.
Validation approaches built for on-premise, custom software often struggle with cloud, SaaS and agile delivery. This session shows how to apply risk-based thinking so validation effort protects data integrity, product quality and patient safety.
It is meant for people who plan, run or support computer system validation in FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products. Relevant functions include R&D, manufacturing, quality control, distribution, clinical testing, labeling, adverse events and post-marketing surveillance.
Validation approaches built for on-premise, custom software often struggle with cloud, SaaS and agile delivery. This session shows how to apply risk-based thinking so validation effort protects data integrity, product quality and patient safety.
It is meant for people who plan, run or support computer system validation in FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products. Relevant functions include R&D, manufacturing, quality control, distribution, clinical testing, labeling, adverse events 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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