Carolyn Troiano
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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 Training available.
21 CFR Part 11, FDA's Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA
Pharmaceutical GAMP®5, Second Edition and Alignment with FDA’s Draft Guidance for Computer Software Assurance (CSA)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Update to FDA's Draft Guidance on 21 CFR Part 11, Electronic Records/Signatures Used for Clinical Investigation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
21 CFR Part 11, FDA Guidance for Electronic Records and Signatures Using a Computer System Regulated by FDA
