This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems used in the conduct of clinical trials that are 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 does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered. Participants will learn about the specific aspects of clinical systems the data required, and how to meet compliance.
Carolyn Troiano
Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and 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 …
The Importance of the first 5 seconds when presenting
Project Management for administrative professionals
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Launch Your Career: The Ultimate Guide for Emerging Profess…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Managing Toxic & Other Employees Who Have Attitude Issues
Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…
Effectively Handle Toxic People for Better Productivity and…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Employee Handbooks: 2025 Critical Issues
Better Business Writing-How to Write Right
The five qualities every successful leader must develop
How to Lead and Manage a Narcissistic Employee
Use of AI and GPT for Finance Professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Analytical Method Validation Under Good Laboratory Practic…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel What-If-Analysis Decision-Making Tools
How to Write Contracts for Procurement Professionals
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People: At Work & In Life
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Retention Starts Here: Stop Losing Your Critical Talent and…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
AI and Human Resources: The Great Opportunity!
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI