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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.

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Featured OnDemand Webinars

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

Duration: 90 Minutes
| Pharmaceutical
| All Days

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Duration: 90 Minutes
| Pharmaceutical
| All Days

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Duration: 60 Minutes
| Pharmaceutical
| All Days

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

Duration: 90 Minutes
| Pharmaceutical
| All Days

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

Duration: 90 Minutes
| Pharmaceutical
| All Days

Update to FDA's Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Strategies for Effective Risk Management in FDA IT Infrastructure Validation

Duration: 90 Minutes
| Pharmaceutical
| All Days

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

Duration: 720 Minutes
| Pharmaceutical
| All Days

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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

GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

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

Update to FDA's Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigation

Strategies for Effective Risk Management in FDA IT Infrastructure Validation

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

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Carolyn Troiano

Live Business Training Events

Featured OnDemand Webinars

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)

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission

Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems

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

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

Strategies for Effective Risk Management in FDA IT Infrastructure Validation

Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech

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