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.
Computer System Validation (CSV) for FDA-Regulated Computers
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 and approach and incorporating it into an overall computer syst ...
- Basic & Intermediate
- 90 Mins
- Jan 06, 2023
Vendor Audit for Systems and Services for FDA-Regulated Systems
This webinar will provide the best industry practices to follow when auditing a vendor of a computer system that is regulated by the FDA. We will discuss the best approach for assessing a vendor’s organization, capability, physical/logical security practices, ...
- Basic & Intermediate
- 90 Mins
- Jan 23, 2023
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
The 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. This includes development of a company philosophy and approach, ...
- Intermediate
- 90 Mins
- Feb 01, 2023
Cloud and Software-as-a-Service (SaaS) Vendors: Approach to Validation for FDA-Regulated System
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device, or other FDA-regulated industries. Th ...
- Basic & Intermediate
- 90 Mins
- Feb 24, 2023
Medical Device Trends in FDA Compliance and Enforcement
This webinar will focus on medical devices, a key concern for FDA as they become more and more complex, and require methodical risk assessment and mitigation. Protecting medical devices from hacking where someone can alter the actual code embedded in the devic ...
- Basic & Intermediate
- 90 Mins
- Mar 01, 2023
Best Practices in Preparation for an FDA Audit of Regulated Computer 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 thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Mar 20, 2023
Best Practices in Preparation for an FDA Audit of Regulated Computer 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 thinking on computer sys ...
- Basic & Intermediate
- 90 Mins
- Mar 20, 2023
Medical Device Cyber security and FDA Compliance
This webinar will focus on the 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 device coul ...
- Basic & Intermediate
- 90 Mins
Best Practices for Preparing for an FDA Computer System Audit
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 thinking on computer sys ...
- Intermediate
- 90 Mins
21 CFR Part 11 Electronic Records/Signatures
The Webinar will focus on the importance of ensuring that the electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes developing a company philosophy and approach ...
- Intermediate
- 90 Mins