# Event Details - **Event Name**: Classic CSV vs CSA: validating systems vs assuring software quality. - **Event Start and End Date**: Tue, 17 Mar, 2026 at 09:00 am – Tue, 17 Mar, 2026 at 05:00 pm - **Event Description**: Classic CSV documents validation activities for regulated systems; CSA focuses on risk-based assurance and critical thinking over paperwork.About this EventOrganizations can begin applying selected CSA principles immediately—even beyond the primary scope of the final guidance—provided they can clearly justify their approach and demonstrate alignment with 21 CFR Part 11, data integrity requirements, the Quality Management System (QMS), and other governing procedures.This seminar presents a comprehensive overview of the evolution from traditional Computer System Validation (CSV) to Computer Software Assurance (CSA). Participants will receive a practical, step-by-step roadmap to support a successful transition within their organization. Key transition activities, required documentation, supporting artifacts, and common challenges will be discussed in detail.A live Q&A session will be included. Additionally, the slide deck contains an appendix illustrating a real-world transition example using a LabWare Laboratory Information Management System (LIMS).This example highlights the level of detail and documentation necessary to effectively shift from CSV to CSA while maintaining regulatory compliance.Life sciences sectors-including pharmaceuticals, medical devices, biotechnology, biologics, and tobacco-related industries-continue adopting advanced technologies to improve product quality while maintaining FDA compliance. Automation has been in place since the late 1970s, prompting the FDA to issue its original Computer System Validation (CSV) guidance in 1983. CSV relies on a structured System Development Life Cycle (SDLC) model, requiring defined activities and documentation throughout a system’s lifecycle.In the 1990s, the industry began transitioning toward paperless operations. This led to the issuance of 21 CFR Part 11 in 1997, establishing regulatory requirements for Electronic Records and Electronic Signatures (ER/ES).By 2002, the FDA formally endorsed a risk-based validation approach, recognizing the rapid expansion of computerized systems across regulated organizations.In 2018, the FDA observed a significant increase in compliance deficiencies related to CFR Parts 211 and 212. The resulting Data Integrity Guidance reinforced existing expectations without introducing new regulations, emphasizing accountability, oversight, and quality culture.In September 2022, the FDA released Draft Guidance for Computer Software Assurance (CSA), signalling a shift away from the document-heavy CSV model. CSA emphasizes risk-based decision-making and critical thinking rather than excessive documentation. ISPE aligned with this shift through the publication of GAMP®5, 2nd Edition in July 2022. CSA became final guidance in September 2025 for medical device manufacturers in manufacturing and quality operations. Broader industry adoption is expected in the near future, while other sectors continue operating under traditional CSV expectations.Since 2015, life sciences organizations have increasingly implemented cloud platforms, SaaS models, AI, ML, and LLM technologies such as ChatGPT. As digital transformation accelerates, ensuring validation, Part 11 compliance, and data integrity within these modern environments has become essential.Learning ObjectivesParticipants will gain the ability to:Comprehend the foundational principles of traditional Computer System Validation (CSV)Examine the GAMP®5 “V” Model frameworkUnderstand the System Development Life Cycle (SDLC) approachApply best practices in validation planning, requirements development, testing, reporting, and traceabilityExplore the CSA methodology and the importance of critical thinkingReview GAMP®5, 2nd Edition and its alignment with CSA principlesDevelop a structured approach for transitioning from CSV to CSAUnderstand the fundamentals of 21 CFR Part 11 (Electronic Records/Electronic Signatures – ER/ES)Identify Part 11 compliance requirements and control expectationsRecognize common Part 11 deficiencies cited during FDA inspectionsStrengthen understanding of data integrity principles and requirementsIdentify frequent data integrity gaps observed during FDA inspectionsUnderstand data lifecycle management conceptsAppreciate the role of data governance and privacy requirementsEvaluate Commercial-Off-the-Shelf (COTS) solutions and associated support considerationsUnderstand cloud computing environments and support requirementsReview Software-as-a-Service (SaaS) models and compliance considerationsUnderstand how Platform-as-a-Service (PaaS) and Infrastructure-as-a-Service (IaaS) support streamlined development and deploymentImplement and manage Single-Sign-On (SSO) capabilitiesConduct effective vendor auditsUnderstand Artificial Intelligence (AI) and Machine Learning (ML) fundamentalsReview Large Language Models (LLMs), including ChatGPTUnderstand Retrieval-Augmented Generation (RAG) conceptsRecognize how Recursive Language Models (RLMs) may extend beyond LLMs and RAGReview FDA’s evolving expectations regarding AI, ML, and LLM useUnderstand industry adoption trends for AI-driven technologiesGain insight into FDA regulatory compliance expectationsReview current FDA enforcement trendsUnderstand various FDA inspection typesConduct effective internal auditsApply industry best practicesAreas CoveredThis session will address:Computer System Validation (CSV)GAMP®5 “V” ModelSystem Development Life Cycle (SDLC)Validation Planning, Requirements, Testing, and ReportingRequirements Traceability Matrix (RTM)Computer Software Assurance (CSA)Critical Thinking in ValidationGAMP®5, 2nd Edition alignment with CSACSV-to-CSA Transition Methodology21 CFR Part 11 (ER/ES) GuidancePart 11 Compliance Requirements and ControlsCommon Part 11 DeficienciesData Integrity (ALCOA+++ Principles)Data Integrity Controls and GapsData Lifecycle ManagementData Governance and PrivacyCOTS SolutionsCloud ServicesSaaS, PaaS, and IaaS EnvironmentsSingle-Sign-On (SSO)Vendor AuditsArtificial Intelligence (AI) and Machine Learning (ML)Large Language Models (LLMs), including ChatGPTRetrieval-Augmented Generation (RAG)Recursive Language Models (RLMs)FDA Regulatory ComplianceEnforcement Trends and Inspection TypesInternal AuditingIndustry Best PracticesQ&AWhy Should You AttendEnsuring the safety and effectiveness of FDA-regulated products remains a shared responsibility across development, manufacturing, testing, and distribution functions.This Seminar explains both CSV and CSA frameworks, highlighting how CSA enables more flexible, risk-based testing approaches suited to emerging technologies such as cloud platforms and SaaS environments. Unlike CSV’s standardized testing model, CSA promotes scalable validation activities driven by risk and critical thinking. Successful adoption requires thoughtful organizational change and leadership engagement.Participants will learn how to transition validation programs from CSV to CSA in alignment with FDA’s 2022 draft and 2025 final guidance (for medical device manufacturing and quality operations). The session also explores how CSA improves SDLC efficiency while maintaining compliance.Additional focus areas include 21 CFR Part 11, data integrity, data lifecycle management, governance, and privacy considerations.This Seminar is designed primarily for professionals within FDA-regulated medical device organizations; however, CSA principles may be cautiously applied across pharmaceutical, tobacco, and software sectors when properly justified and documented.Attend if you are responsible for implementing, managing, validating, maintaining, or auditing FDA-regulated computerized systems. Gain practical guidance, best practices, and actionable strategies to implement CSA while maintaining regulatory compliance.Participants will also learn how to establish the necessary policies, procedures, and documentation required to support a successful CSV-to-CSA transition.Who Should AttendThis program benefits professionals in roles such as:IT AnalystsSoftware Developers and TestersIT Support and Security TeamsProduction and Supply Chain ManagersClinical Data Managers and ScientistsCRO and CDMO PersonnelCompliance Managers and AuditorsLaboratory Managers and AnalystsQuality AuditorsComputer System Validation SpecialistsGMP, GLP, and GCP Training ProfessionalsBusiness Stakeholders Using FDA-Regulated SystemsRegulatory Affairs and Submissions PersonnelLife Science ConsultantsInterns in FDA-regulated industriesIndustries impacted include:PharmaceuticalMedical DeviceBiologicsTobacco and Related ProductsCannabis and Vapor ProductsSoftware-as-a-Medical-Device (SaMD) DevelopersSoftware Vendors Serving FDA-Regulated SectorsThird-Party Service Providers (including CROs)Academic Institutions Offering FDA-Related ProgramsEvent ItineraryModule 1: CSV, CSA, and GAMP®5 (2nd Edition) Alignment with CSA(9:00 am - 10:00 am; 1 Hour)Each Section Below - 5-10 MinutesReview of Classical Computer System Validation (CSV) ApproachReview of GAMP®5 "V" ModelReview of System Development Life Cycle (SDLC)Validation Planning, Requirements, Testing, Reporting, and TraceabilityComputer Software Assurance (CSA) Approach and Critical ThinkingReview of GAMP®5, 2nd Edition and Alignment with CSAHow to Transition from CSV to CSAModule 2: 21 CFR Part 11 - Electronic Records/Electronic Signatures (ER/ES)(10:00 am - 10:30 am; 30 Minutes)Each Section Below - 15 Minutes21 CFR Part 11 Guidance (ER/ES) Overview21 CFR Part 11 Requirements & ControlsBREAK(10:30 am - 10:40 am; 10 Minutes)Module 3 - Continued(10:40 am - 11:00 am; 20 Minutes)Section Below - 20 Minutes21 CFR Part 11 DeficienciesModule 4: Data Integrity and Governance(11:00 am - 12:00 pm; 1 Hour)Each Section Below - 10 MinutesData Integrity Guidance OverviewData Integrity Requirements & ControlsData Integrity DeficienciesData Life CycleData GovernanceData PrivacyLunch Break(12:00 pm - 1:00 pm; 1 Hour)Module 5: Commercial Off-the-Shelf (COTS), Cloud, SaaS(1:00 pm - 2:00 pm; 1 Hour)Each Section Below - 10 MinutesCOTS Solutions & SupportCloud Services & SupportSaaS Solutions & SupportPaaS & IaaSSingle-Sign-On (SSO) CapabilityVendor AuditModule 6: AI, ML, & LLMs(2:00 pm - 2:30 pm; 30 Minutes)Each Section Below - 5-10 MinutesArtificial Intelligence (AI) & Machine Learning (ML) ConceptsLarge Language Models (LLMs), including ChatGPTRetrieval-Augmented Generation (RAG)Recursive Language Models (RLMs)BREAK(2:30 pm - 2:40 pm; 10 Minutes)Module 7 - Continued(2:40 pm - 3:00 pm; 20 Minutes)Each Section Below - 10 MinutesFDA Focus on Use of AI, ML, & LLMsIndustry Focus on Use of AI, ML, & LLMsModule 8: FDA Trends in Compliance & Enforcement(3:00 pm - 4:00 pm; 1 Hour)Each Section Below - 30 MinutesFDA Regulatory ComplianceFDA Regulatory Enforcement TrendsModule 9: Inspection Readiness(4:00 pm - 4:45 pm; 45 Minutes)Each Section Below - 15 MinutesFDA Inspection TypesInternal AuditIndustry Best PracticesQ&A(4:45 pm - 5:00 pm; 15 Minutes)Speaker DetailsCarolyn Troiano brings more than 45 years of experience across pharmaceutical, medical device, tobacco, and other FDA-regulated industries. She has supported numerous major organizations in the United States and Europe, developing and implementing regulatory compliance strategies. Her expertise includes Computer System Validation (CSV), Computer Software Assurance (CSA), SDLC methodologies (both waterfall and agile), GAMP®5 2nd Edition, 21 CFR Part 11 compliance, Electronic Records and Electronic Signatures (ER/ES), Data Integrity, and Data Privacy. Carolyn has led the implementation and validation of large-scale, enterprise-wide systems across multiple GxP environments. She provides industry training through webinars and seminars and offers consulting services to life science organizations worldwide. - **Event URL**: https://allevents.in/warren/classic-csv-vs-csa-validating-systems-vs-assuring-software-quality/100001983860454022 - **Event Categories**: workshops, artificial-intelligence, nonprofit, virtual, webinar, it - **Interested Audience**: - total_interested_count: 0 ## Ticket Details - **Ticket Price Range**: min: 705.04, max: 705.04, currency: USD ## Event venue details - **city**: Warren - **state**: NJ - **country**: United States - **location**: Somerset Hills Hotel, Tapestry Collection by Hilton - **lat**: 40.6541608 - **long**: -74.5748416 - **full address**: Somerset Hills Hotel, Tapestry Collection by Hilton, 200 Liberty Corner Road, Warren, United States ## Event gallery - **Alt text**: Classic CSV vs CSA: validating systems vs assuring software quality. - **Image URL**: https://cdn-az.allevents.in/events10/banners/23c194cd750b0ccac7c04b987bfeddccd288299b8a5f414b747f5df3018f8e0d-rimg-w1200-h600-dc040404-gmir.jpg?v=1771979632 ## FAQs - **Q**: When and where is Classic CSV vs CSA: validating systems vs assuring software quality. being held? - **A:** Classic CSV vs CSA: validating systems vs assuring software quality. takes place on Tue, 17 Mar, 2026 at 09:00 am to Tue, 17 Mar, 2026 at 05:00 pm at Somerset Hills Hotel, Tapestry Collection by Hilton, 200 Liberty Corner Road, Warren, United States. - **Q**: How much do tickets cost for Classic CSV vs CSA: validating systems vs assuring software quality.? - **A:** Tickets for Classic CSV vs CSA: validating systems vs assuring software quality. are priced at USD 705 per person. Here's a full breakdown of available ticket types:Ticket TypePriceAvailabilityIn-Person SeminarUSD 705 + USD 46 feeAvailable - **Q**: Who is organizing Classic CSV vs CSA: validating systems vs assuring software quality.? - **A:** Classic CSV vs CSA: validating systems vs assuring software quality. is organized by WebinarWaves. - **Q**: Who is this event for? Is it right for me? - **A:** Classic CSV vs CSA: validating systems vs assuring software quality. is ideal for curious learners, students, and skill-builders looking to gain hands-on knowledge and practical expertise in a focused, interactive setting. Whether you're a first-time attendee or a longtime enthusiast in Warren, this event is thoughtfully curated to deliver a standout experience worth every moment. 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