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Carolyn Troiano
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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Webinar
21 CFR Part 11 - FDA's Guidance for Electronic Records and Electronic Signatures
21 CFR Part 11 - FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano
25 Feb 2022, Friday 
1:00 PM EST 
90 Mins WEB0014525 Feb 2022, Friday 10:00 AM PDT This webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.
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Data Integrity Compliance for Computer Systems Regulated by FDA
Data Integrity Compliance for Computer Systems Regulated by FDA
Carolyn Troiano
18 Oct 2021, Monday 1:00 PM EST 90 Mins WEB0016318 Oct 2021, Monday 10:00 AM PDT The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.
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Best Practices in Preparation for an FDA Computer System Audit
Best Practices in Preparation for an FDA Computer System Audit
Carolyn Troiano
20 Sep 2022, Tuesday 1:00 PM EST 90 Mins WEB0143720 Sep 2022, Tuesday 10:00 AM PDT It’s important to know what to expect during an FDA audit. Before you are scheduled for a Computer System Audit, we recommend that you review our tips and best practices below.
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Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Carolyn Troiano
28 Apr 2023, Friday 3:00 PM EST 90 Mins WEB0146128 Apr 2023, Friday 12:00 PM PDT This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC).
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FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance
FDA Modernization and Restructuring of the SDLC for Computer System Validation and Compliance
Carolyn Troiano
22 Apr 2022, Friday 1:00 PM EST 90 Mins WEB0147122 Apr 2022, Friday 10:00 AM PDT The attendee will learn about ways to modernize the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV) by using automated testing tools.
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Medical Device Cybersecurity and FDA Compliance
Medical Device Cybersecurity and FDA Compliance
Carolyn Troiano
14 Jun 2022, Tuesday 1:00 PM EST 90 Mins WEB1449814 Jun 2022, Tuesday 10:00 AM PDT This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products.
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