Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.
Live Webinars
By: Carolyn Troiano
Nov. 25, 2024
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.
Certain documents, content and images related to a clinical trial must be…
Industry: Pharmaceutical Duration: 90 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
By: Carolyn Troiano
Dec. 6, 2024
FDA Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data Integrity
For over three decades, the FDA has regulated computer system validation in industries like pharmaceuticals, biotechnology, and medical devices. These validations ensure that computer systems invo…
Industry: FDA Compliance Duration: 90 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
Chronicles
By: Carolyn Troiano
Recorded Session
The 6 Most Common Problems in FDA Software Validation and Verification Computer System Validation Step-by-Step
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to F…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
FDAs Recent Clarification on Guidance for Managing Data Integrity for Regulated Computer Systems
The webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines. This includes the development of a company philosophy …
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also atten…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device, or other FDA-regulated indu…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
Data Governance for Computer Systems Regulated by FDA
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device, or other FDA-regulated indu…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
FDA Compliance and Clinical Trial Computer System Validation
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems used in the …
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to…
Industry: FDA Compliance Duration: 60 Minutes
By: Carolyn Troiano
Recorded Session
GAMP5, Second Edition and Alignment with Computer Software Assurance (CSA) and Digital Validation
We will explore the latest best industry practices offered in GAMP®5 (Second Edition) and understand what it offers to those validation computer systems in the FDA-regulated industries. We wil…
Industry: Medical Devices Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)
The TMF includes all of the documentation that a sponsor must record to demonstrate that they have met their obligations for the conduct of a clinical trial. Alternatively, an electronic Trial Mas…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers w…
Industry: Medical Devices Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
In today's ever-changing landscape of technology, there are many new considerations for computer system validation (CSV) to ensure the nuances of each innovative component. For example, we now…
Industry: FDA Compliance Duration: 90 Minutes
By: Carolyn Troiano
Recorded Session
FDA Compliance And Laboratory Computer System Validation
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development…
Industry: FDA Compliance Duration: 90 Minutes