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Carolyn Troiano

Carolyn Troiano

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  • 4.4 / 5

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.

FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
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FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
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  • 4.4
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In-Depth Functional and System Requirements for Computer Systems Regulated by FDA
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In-Depth Functional and System Requirements for Computer Systems Regulated by FDA
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  • 4.6
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Good Documentation Practices to Support FDA Computer System Validation
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Good Documentation Practices to Support FDA Computer System Validation
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  • 4.3
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In-Depth Testing of Computer Systems Regulated by FDA
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In-Depth Testing of Computer Systems Regulated by FDA
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  • 4.3
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Trends in FDA Compliance and Enforcement for Regulated Systems
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Trends in FDA Compliance and Enforcement for Regulated Systems
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  • 4.5
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Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
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Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
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  • 4.4
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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
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Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA
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  • 4.7
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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
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Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
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  • 4.5
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Best Practices in Preparation for an FDA Computer System Audit
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Best Practices in Preparation for an FDA Computer System Audit
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  • 4.3
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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
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  • 4.2
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
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  • 4.3
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Data Integrity and Data Governance for Computer Systems Regulated by FDA
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Data Integrity and Data Governance for Computer Systems Regulated by FDA
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  • 4.5
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