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Author:

Carolyn Troiano


Courses

Computer System Validation (CSV) Basics
Apr 21 The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$189
Webinar Validating FDA-Regulated Systems Using AI, ML & LLMs, such as ChatGPT
Apr 28, 2026, Duration 90 mins, learn about how AI increasing in use in the life sciences industries, and how companies are leading the way to delivering more effective, safer, and more beneficial products as a result.
Carolyn Troiano Carolyn Troiano
$189
Validating FDA-Regulated Systems Supporting Drug Development & Submissions Using AI, ML & LLMs, such as ChatGPT
May 14 This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.
Carolyn Troiano Carolyn Troiano
$189
Fundamentals of Part 11 Webinar
May 18 The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems
Carolyn Troiano Carolyn Troiano
$189
How to use ChatGPT & AI for Project Management of Computer System Validation to Improve FDA Compliance
Jun 04 In this webinar, we’ll discuss using a project management approach and techniques to validate a computer system regulated by FDA. In addition, we’ll talk about the 5 phases of a project, showing how these align with validation.
Carolyn Troiano Carolyn Troiano
$189
CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems Course
June 16-17, 2026, this 2-day in-person workshop in Richmond, Virginia provides a practical guide to transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) within U.S. Food and Drug Administration-regulated environments. Participants will gain a clear understanding of how to apply CSA principles while maintaining compliance with 21 CFR Part 11, data integrity, and data privacy requirements.
Carolyn Troiano Carolyn Troiano
$2,295
Spreadsheet Validation Webinar
June 25 This webinar is intended for those involved in planning, execution and support of computer system validation activities, working
Carolyn Troiano Carolyn Troiano
$189
Computer System Validation ( CSV) 3 Day Seminar
August 4-6, 2026, 3-day CSV course will teach you how to comply with key FDA and international CSV
Carolyn Troiano Carolyn Troiano
$1,495
Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech
Aug 20-21 This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano Carolyn Troiano
$1,495
Cloud and SaaS in GxP Webinar
MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$189
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
MP3 Download The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.
Carolyn Troiano Carolyn Troiano
$499
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
MP3 Download In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano Carolyn Troiano
$249
Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities
MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition, published in July 2022,
Carolyn Troiano Carolyn Troiano
$1,495
FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance
MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA
Carolyn Troiano Carolyn Troiano
$199
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$199
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.
Carolyn Troiano Carolyn Troiano
$1,495
Computer System Validation for Cloud and COTS Applications–Live, Online Training
MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$1,495
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
MP3 Download The attendee will learn a simple way to address both data integrity and Part 11 aspects of the system, focusing on risk and critical thinking
Carolyn Troiano Carolyn Troiano
$895
Introduction to Computer System Validation
MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
Carolyn Troiano Carolyn Troiano
$1,295
GAMP® 5 Second Edition – The changes and its impacts that you should know
MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition
Carolyn Troiano Carolyn Troiano
$499
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations
Carolyn Troiano Carolyn Troiano
$495
All About Data Integrity by Design
MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products
Carolyn Troiano Carolyn Troiano
$1,295
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.
Carolyn Troiano Carolyn Troiano
$189
FDA Compliance and Laboratory Computer System Validation
MP3 Download This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco
Carolyn Troiano Carolyn Troiano
$189
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
MP3 Download 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
Carolyn Troiano Carolyn Troiano
$189
Risk-Based Validation of Spreadsheet Applications
MP3 Deownload This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries
Carolyn Troiano Carolyn Troiano
$189
Project Management for Computer System Validation (CSV) to Improve FDA Compliance
MP3 Download We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$189
Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity
MP3 Download The attendee will learn about ways to approach the computer system validation of any FDA-regulated system. There are traditional methods that have been followed for decades now, but these document-driven efforts
Carolyn Troiano Carolyn Troiano
$189
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
Carolyn Troiano Carolyn Troiano
$189
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
MP3 Download During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data
Carolyn Troiano Carolyn Troiano
$189
Trial Master File and Clinical Data Management Regulated by FDA
MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano Carolyn Troiano
$189
FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations
MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products
Carolyn Troiano Carolyn Troiano
$199
Traditional Computer System Validation and More Novel Computer Software Assurance (CSA): Finding the Best Approach
MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$199
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each
Carolyn Troiano Carolyn Troiano
$189
FDA Compliance and Enforcement Trends focused on Data Integrity
MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits
Carolyn Troiano Carolyn Troiano
$249
FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You
MP3 Download This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products
Carolyn Troiano Carolyn Troiano
$249