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Carolyn Troiano

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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 Webinar

Recorded Session

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By: Carolyn Troiano

Recorded Session

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  

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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

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

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to add…

Industry: FDA Compliance   Duration: 60 Minutes  

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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