Carolyn Troiano

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.

No live webinars available.

1

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Apr 01 ,2025 - To: 2025-12-31

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Update to FDA’s Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigations

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jun 14 ,2024 - To: 2024-12-31

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: May 23 ,2024 - To: 2024-12-31

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Apr 16 ,2024 - To: 2024-12-31

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FDA’s Recent Draft Guidance Related to 21 CFR Part 11, Electronic Records/Signatures for Clinical Investigations

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jan 30 ,2024 - To: 2024-04-05

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Dec 20 ,2023 - To: 2024-01-03

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

Recorded Webinar

Pharmaceutical

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

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COTS, Cloud, and SaaS Systems and FDA Validation Compliance

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Oct 10 ,2023 - To: 2023-12-31

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jul 03 ,2023 - To: 2023-12-31

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GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jun 01 ,2023 - To: 2023-12-31

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Dec 16 ,2022 - To: 2022-12-31

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6 - Hour Boot Camp on Computer System Validation – Managing Computers Regulated by FDA

Recorded Webinar

Pharmaceutical

Duration: 360 Minutes | From: Dec 15 ,2022 - To: 2022-12-31

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

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Dec 09 ,2022 - To: 2022-12-31

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Clinical Trial Compliance for Computer Systems and Data Regulated by FDA - Trial Master File (TMF) and electron

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Oct 19 ,2022 - To: 2022-12-31

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Good Documentation Practice (GDP) and Compliance for Computer Systems Regulated by FDA

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Aug 15 ,2022 - To: 2022-08-20

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Medical Device Cybertechnology and FDA Compliance

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Aug 04 ,2022 - To: 2022-12-31

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Data Integrity and Governance for Computer Systems Regulated by FDA

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jul 11 ,2022 - To: 2022-12-31

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Trends in FDA Compliance and Enforcement for Regulated Systems

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Jun 21 ,2022 - To: 2022-12-31

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Computer System Validation (CSV) vs. Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance

Recorded Webinar

Pharmaceutical

Duration: 90 Minutes | From: Oct 22 ,2021 - To: 2021-12-31

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