Ms.Carolyn Troiano

Area Of Expertise : Computer System Validation
40 Years Of Experience
Training Industry : Life Sciences

Carolyn Troiano has more than 40+ 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.

 

 

49 results Found
Live Webinar

Best Practices in Preparation 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 syst ...

  • Intermediate
  • 90 Mins
  • Jul 25, 2025
Live Webinar

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Qu ...

  • Basic & Intermediate & Advanced
  • 90 Mins
  • Aug 04, 2025
Live Webinar

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 Life Cycle (SDLC) framework. They will have received the guidan ...

  • Basic & Advanced
  • 60 Mins
  • Aug 08, 2025
Live Webinar

Integration of ERP and Legacy FDA-Regulated Systems

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory s ...

  • Basic & Advanced
  • 60 Mins
  • Aug 15, 2025
Live Webinar

Pharma 4.0: Next Generation Technology Approach to GxP Products, Systems, Data, & FDA Compliance

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.  The ...

  • Intermediate
  • 90 Mins
  • Sep 05, 2025
Live Webinar

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

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 vendor audit ...

  • Intermediate
  • 90 Mins
  • Sep 08, 2025
Live Webinar

Artificial Intelligence (AI), Machine Learning, and FDA Compliance for Computer Systems and Data

As the pace of technological innovation and evolution becomes more intense, there is a critical need for computer system validation, 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliance, and data integrity assurance to continue in environme ...

  • Intermediate
  • 90 Mins
  • Sep 17, 2025
Live Webinar

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 attendees will learn in detail about the System Development Life Cycle (SDL ...

  • Basic & Intermediate & Advanced
  • 60 Mins
  • Sep 25, 2025
Live Webinar

Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to ...

  • Intermediate
  • 90 Mins
  • Oct 03, 2025
Live Webinar

Trends in FDA Compliance and Enforcement for Regulated Systems

This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data in ...

  • Intermediate
  • 90 Mins
  • Oct 07, 2025