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 project management instructor for non-profit organizations.
Live Webinars
By: Carolyn Troiano
Nov. 6, 2026
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
The FDA has regulated computer system validation in pharmaceuticals, biotechnology and medical devices for more than 30 years. With its Technology Modernization Action Plan (TMAP), the agency is c…
Industry: FDA Compliance Duration: 90 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
By: Carolyn Troiano
July 3, 2026
Validation of FDA-Regulated Medical Device and SaMD Products Using AI, ML, and LLMs, such as ChatGPT
FDA is modernizing how it works with data, and AI, machine learning (ML) and large language models (LLMs) such as ChatGPT are changing how medical device and SaMD products are built and reviewed. …
Industry: FDA Compliance Duration: 90 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
Chronicles
By: Carolyn Troiano
Recorded Session
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
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 webina…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
FDA Compliance And Laboratory Computer System Validation
Laboratory computer system validation is critical for any FDA-regulated organization, but the volume of guidance can be overwhelming. This 90-minute webinar condenses decades of industry best prac…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026
Data integrity and privacy risks are not limited to one team. They appear wherever regulated data is created, reviewed, moved or relied on, from quality and IT to labs, clinical, manufacturing and…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
The Trial Master File (TMF) holds the documentation a sponsor needs to show it met its obligations in running a clinical trial. This 90-minute TMF and eTMF training explains what goes in it, how t…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
Using electronic records and signatures (ER/ES) under 21 CFR Part 11 brings specific controls: removing print capability so decisions rest on the electronic record, verifying that the signer is th…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
FDA Compliance and Clinical Trial Computer System Validation
Computer system validation (CSV) proves that a system does what it claims and keeps it validated from conception to retirement. This 90-minute webinar explains how to apply the System Development …
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
For pharmaceutical, biologics, vaccine, tobacco, animal health, medical device and other FDA-regulated companies, managing computer system data compliantly is critical. Thirty years of best practi…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
Organizations in FDA-regulated industries, from pharmaceuticals, biologics and vaccines to tobacco, animal health and medical devices, depend on compliant computer system data management. Best pra…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
FDA expects computer systems used in regulated work to be classified, risk-assessed, tested and validated so they do what they claim to do. This 90-minute data governance and computer system valid…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
FDA continues to focus heavily on data integrity during inspections, and validation of regulated computer systems has to show clearly that each system does what it is meant to do. This 60-minute w…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step
Validating a computer system subject to FDA regulations means proving it does what it is supposed to do and keeping it in a validated state from conception to retirement. This 90-minute computer s…
Industry: FDA Compliance Duration: 90 Minutes