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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 …

Expert Speaker

Compliance Specialist

Medical Devices COTS, Cloud, and SaaS Systems and FDA Validation Compliance

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 18 Aug, 2025 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 21 Apr, 2025 (Recorded Session)

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FDA Compliance FDA Compliance And Laboratory Computer System Validation

FDA Compliance And Laboratory Computer System Validation

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 17 Mar, 2025 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 19 Sep, 2024 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 31 May, 2024 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 60 Minutes Minutes

Date: 30 Oct, 2023 (Recorded Session)

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FDA Compliance FDA Compliance and Clinical Trial Computer System Validation

FDA Compliance and Clinical Trial Computer System Validation

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 04 Oct, 2023 (Recorded Session)

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FDA Compliance Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 60 Minutes Minutes

Date: 08 Dec, 2022 (Recorded Session)

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FDA Compliance Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 60 Minutes Minutes

Date: 19 Apr, 2022 (Recorded Session)

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FDA Compliance Data Governance for Computer Systems Regulated by FDA

Data Governance for Computer Systems Regulated by FDA

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 08 Feb, 2022 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 60 Minutes Minutes

Date: 20 Feb, 2020 (Recorded Session)

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

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

Speaker: Carolyn Troiano

Duration: 90 Minutes Minutes

Date: 04 Dec, 2019 (Recorded Session)

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