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Validity : 29th Jun'22 to 09th Jul'22
Ms.Carolyn Troiano
Area Of Expertise : Computer System Validation
30 Years Of Experience
Training Industry : Life Sciences
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.
21 results Found
Live Webinar
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
- Jul 05, 2022
Live Webinar
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
- Jul 25, 2022
On-Demand Webinar
21 CFR Part 11 (Electronic Records and Signatures) Compliance for Computer Systems Regulated by FDA
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
Free Webinar
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 practices, requ ...
- Intermediate
- 90 Mins
Free Webinar
FDA's Two Guidance on Software and Device Changes and the 510(k)
This course is intended to provide an overview of 2 FDA guidance documents that clarify when medical device and software manufacturers must file a 510(k) (premarket notification) for changes to an existing device and/or software integrated with a device. The ...
- Intermediate
- 90 Mins
Free Webinar
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 regulatory jurisdicti ...
- Intermediate
- 90 Mins
Free Webinar
FDA’s 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 development of a company philosophy and approach, and incorporating it into an overall computer system v ...
- Intermediate
- 90 Mins
Recorded Webinar
FDA Compliance and Mobile Applications
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system do ...
- Intermediate
- 90 Mins
Recorded Webinar
Current Trends in Cyber security Threats for Medical Devices
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 device could res ...
- Intermediate
- 90 Mins
Free Webinar
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 thinking on computer syste ...
- Intermediate
- 90 Mins