Understanding Classic Computer System Validation (CSV) & Computer Software Assurance (CSA) - Seminar скачать в хорошем качестве

Understanding Classic Computer System Validation (CSV) & Computer Software Assurance (CSA) - Seminar

Register ‪@conferencepanel3305‬ for the full video, https://conferencepanel.com/seminar-d... In this full-day seminar, industry expert Carolyn Troiano provided a step-by-step roadmap for transitioning from CSV to CSA, while maintaining compliance with 21 CFR Part 11, FDA data integrity guidance, and Quality Management System (QMS) requirements. This seminar is designed for professionals working in pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries who are responsible for validation, compliance, IT systems, quality oversight, and inspection readiness. Why the Transition from CSV to CSA Matters in 2026 With the FDA finalizing CSA guidance and increasing focus on: Risk-based validation approaches Data integrity (ALCOA++ principles) AI, ML, and LLM usage Cloud and SaaS environments FDA inspection enforcement trends Organizations must modernize their validation strategies. This seminar explains how to: Replace document-heavy CSV processes Apply critical thinking in CSA Align with GAMP®5, 2nd Edition Prepare for FDA audits and inspections During this seminar, the following areas will be covered: Computer System Validation (CSV) GAMP®5 “V” Model System Development Life Cycle (SDLC) methodology Validation Planning Validation Requirements Validation Testing Validation Reporting Requirements Traceability Matrix (RTM) Computer Software Assurance (CSA) Critical Thinking GAMP®5, 2nd Edition, and its alignment with CSA Transition from CSV to CSA 21 CFR Part 11 Guidance (ER/ES) 21 CFR Part 11 Requirements and Controls Common 21 CFR Part 11 Deficiencies Data Integrity Guidance (ALCOA+++ Principles) Data Integrity Requirements and Controls Common Data Integrity Deficiencies Data Life Cycle Management Data Governance Data Privacy Commercial-Off-the-Shelf (COTS) solutions Cloud Services Software-as-a-Service (SaaS) Solutions Platform-as-a-Service (PaaS) Solutions Infrastructure-as-a-Service (IaaS) Solutions Single-Sign-On (SSO) Vendor Audit Artificial Intelligence (AI) Machine Learning (ML) Large Language Models (LLMs), including ChatGPT Retrieval-Augmented Generation (RAG) Recursive Language Models (RLMs) FDA Regulatory Compliance Current FDA Regulatory Enforcement Trends FDA Inspection Types Internal Audit Industry Best Practices Agenda:- Module 1: CSV, CSA, and GAMP®5 (2nd Edition) Alignment with CSA Module 2: 21 CFR Part 11 – Electronic Records/Electronic Signatures (ER/ES) Module 3: Data Integrity and Governance Module 4: Commercial Off-the-Shelf (COTS), Cloud, SaaS Module 5: AI, ML, & LLMs Module 6: FDA Trends in Compliance & Enforcement Module 7: Inspection Readiness Speaker: Carolyn Troiano Carolyn Troiano has more than 45 years of experience in the pharmaceutical, medical device, tobacco, and other FDA-regulated industries. Carolyn’s expertise includes traditional Computer System Validation (CSV), Computer Software Assurance (CSA), the System Development Life Cycle (SDLC) Methodology (waterfall and agile), GAMP®5, 2nd Edition, 21 CFR Part 11, FDA’s Guidance for Electronic Records and Electronic Signatures, Data Integrity, and Data Privacy. Carolyn provides webinar and seminar training, as well as consulting with life science industry clients. Why does this matter? With evolving expectations from regulatory bodies like the FDA, adopting CSA is no longer optional—it’s essential for maintaining compliance while improving efficiency. Know more @conferencepanel3305 Visit us - https://conferencepanel.com Email - cs@conferencepanel.com Call - +1-800-803-7592 Read the latest Blogs - https://conferencepanel.com/blog Follow us on LinkedIn-   / conferencepanel   Twitter-   / confrencepanel   Facebook:-   / conferencepanel   YouTube:-    / @conferencepanel3305   Pinterest:-   / conference_panel   Please watch the full video. We hope you will like it and help us grow. Don’t forget to subscribe to our YouTube channel for upcoming videos. Thanks for your support. Want to attend our upcoming sessions? Stay tuned for more expert-led seminars and webinars designed to keep you ahead in compliance and validation trends. Don’t forget to: 👍 Like 💬 Comment your thoughts 🔔 Subscribe for more compliance & validation insights #csv #csa #ComputerSystemValidation #ComputerSoftwareAssurance #pharmacompliance #lifesciences #fda #validation #regulatorycompliance #qualityassurance #gxp #compliancetraining #conferencepanel #riskmanagement #dataintegrity #ai #machinelearning #artificialintelligence #sdlc #21cfr #21cfrpart11 #pharmaceutical #medicaldevices #biotechnology #electronicsignature #electronicrecord #medicaldeviceindustry #gmp #glp #gcp #chatgpt #pharma #pharmaceuticals #pharmacology #qualitymanagementsystem #qualitymanagement #fdainspection #softwareasaservice #fdaaudits #csvtocsa #llm