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Carolyn Troiano

Biography:

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Live Webinar

Recorded Webinar

Carolyn Troiano

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

Live Webinar
Pharmaceutical

Duration: 90 Minutes
Date: Apr 01, 2025 | , 01 : 00 PM EST | 78 Days Left
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Carolyn Troiano

Update to FDA’s Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigations

Pharmaceutical

Duration: 90 Minutes |
From: Jun 14, 2024 - To: Dec 31, 2024
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Carolyn Troiano

Pharma 4.0: Next Generation Technology Approach to GxP Products, and FDA Compliance

Pharmaceutical

Duration: 90 Minutes |
From: May 23, 2024 - To: Dec 31, 2024
| View Conference

Carolyn Troiano

Validation of an FDA-Regulated System that Includes Artificial Intelligence (AI) and Machine Learning (ML)

Pharmaceutical

Duration: 90 Minutes |
From: Apr 16, 2024 - To: Dec 31, 2024
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Carolyn Troiano

FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

Pharmaceutical

Duration: 90 Minutes |
From: Jan 30, 2024 - To: Apr 05, 2024
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Carolyn Troiano

CSV vs. CSA: Aligning the Agile Methodology to the GAMP 5 “V” Model and SDLC Methodology

Pharmaceutical

Duration: 90 Minutes |
From: Dec 20, 2023 - To: Jan 03, 2024
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Carolyn Troiano

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Pharmaceutical

Duration: 90 Minutes |
From: Dec 12, 2023 - To: Dec 31, 2023
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Carolyn Troiano

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Pharmaceutical

Duration: 90 Minutes |
From: Oct 10, 2023 - To: Dec 31, 2023
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Carolyn Troiano

21 CFR Part 11, FDA’s Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

Pharmaceutical

Duration: 90 Minutes |
From: Jul 03, 2023 - To: Dec 31, 2023
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Carolyn Troiano

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Pharmaceutical

Duration: 90 Minutes |
From: Jun 01, 2023 - To: Dec 31, 2023
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Carolyn Troiano

Pharma 4.0 and the Future of Validation of Computer Systems Regulated by FDA

Pharmaceutical

Duration: 90 Minutes |
From: Dec 16, 2022 - To: Dec 31, 2022
| View Conference

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Carolyn Troiano

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

Update to FDA’s Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigations

Pharma 4.0: Next Generation Technology Approach to GxP Products, and FDA Compliance

Validation of an FDA-Regulated System that Includes Artificial Intelligence (AI) and Machine Learning (ML)

FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

CSV vs. CSA: Aligning the Agile Methodology to the GAMP 5 “V” Model and SDLC Methodology

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

21 CFR Part 11, FDA’s Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Pharma 4.0 and the Future of Validation of Computer Systems Regulated by FDA

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Carolyn Troiano

Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders and Systems

Update to FDA’s Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigations

Pharma 4.0: Next Generation Technology Approach to GxP Products, and FDA Compliance

Validation of an FDA-Regulated System that Includes Artificial Intelligence (AI) and Machine Learning (ML)

FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

CSV vs. CSA: Aligning the Agile Methodology to the GAMP 5 “V” Model and SDLC Methodology

Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

COTS, Cloud, and SaaS Systems and FDA Validation Compliance

21 CFR Part 11, FDA’s Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Pharma 4.0 and the Future of Validation of Computer Systems Regulated by FDA

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EIx2W3

Speaker Opportunity

rmLYEP

Suggest a Topic

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