Ms. Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She 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.
Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into ...
- Intermediate
- 90 Mins
- Jun 19, 2019
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)
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 stored and maintained, and depending on the r ...
- Intermediate
- 90 Mins
- Jul 09, 2019
FDA Compliance Trends for Computer System Validation
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA’s current thinki ...
- Intermediate
- 90 Mins
21 CFR Part 11 (Electronic Records/Electronic Signatures) Compliance for Computer Systems Regulated by FDA
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as m ...
- Intermediate
- 90 Mins
Trends in FDA Compliance and Enforcement for Regulated Systems
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current think ...
- Intermediate
- 90 Mins
Data Governance for Computer Systems Regulated by FDA
After attending this course, you will understand data governance as a quality control discipline for assessing, managing, using, improving, monitoring, maintaining, and protecting organizational information. It is a system of decision right ...
- Intermediate
- 90 Mins
Disaster Recovery and Business Continuity for Computer Systems Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal he ...
- Intermediate
- 90 Mins
Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products. Protecting medical devices from hacking where someone can alter the actual code embedded in the dev ...
- Intermediate
- 90 Mins
Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security pr ...
- Intermediate
- 90 Mins
Tobacco Industry Trends for Computer Systems Regulated by FDA
The Tobacco Control Act went into effect by FDA on June 22, 2009. Through this ruling, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule, Deeming Tobacco Products ...
- Intermediate
- 90 Mins