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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

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By: Carolyn Troiano

March 11, 2024

GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation

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 wil…

Industry: Medical Devices   Duration: 90 Minutes   Time: 10:00 AM PDT | 01:00 PM EDT

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By: Carolyn Troiano

April 10, 2024

FDA Compliance And Laboratory Computer System Validation

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development…

Industry: FDA Compliance   Duration: 60 Minutes   Time: 10:00 AM PDT | 01:00 PM EDT

Chronicles

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By: Carolyn Troiano

Recorded Session

The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to F…

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Carolyn Troiano

Recorded Session

FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems

The webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy …

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Carolyn Troiano

Recorded Session

Data Governance for Computer Systems Regulated by FDA

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also atten…

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Carolyn Troiano

Recorded Session

Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device, or other FDA-regulated indu…

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Carolyn Troiano

Recorded Session

Data Governance for Computer Systems Regulated by FDA

Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device, or other FDA-regulated indu…

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Carolyn Troiano

Recorded Session

FDA Compliance and Clinical Trial Computer System Validation

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems used in the …

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Carolyn Troiano

Recorded Session

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to…

Industry: FDA Compliance   Duration: 60 Minutes  

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By: Carolyn Troiano

Recorded Session

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

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…

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Carolyn Troiano

Recorded Session

FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity

For over three decades, the FDA has regulated computer system validation in industries like pharmaceuticals, biotechnology, and medical devices. These validations ensure that computer systems invo…

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Carolyn Troiano

Recorded Session

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial. Alternatively, an electronic Trial Mas…

Industry: FDA Compliance   Duration: 90 Minutes