# Event Details - **Event Name**: Master CSV to CSA: AI validation and inspection readiness - **Event Start and End Date**: Tue, 16 Jun, 2026 at 09:00 am – Wed, 17 Jun, 2026 at 05:00 pm - **Event Description**: Navigate CSV to CSA with smart strategies for AI validation, data integrity, and FDA inspection-ready complianceAbout this EventWe can begin using some of the CSA principles today, even outside of the intended focus for the final guidance. This is provided that for these other areas, we are able to adequately explain their use and defend the tie-in to Part 11, data integrity, the Quality Management System (QMS), and other relevant documents and programs.In this webinar, we’ll provide an overview of the transition process in going from CSV to CSA. We’ll then dive into a step-by-step guide for the transition that can be done by any company. The transition steps, related documents, and other artifacts, and the potential issues to watch out for will be laid out very carefully.The FDA is currently trying to modernize its systems and use of data. The FDA announced all the agency’s centers must fully integrate generative AI into work by the end of June 2025. The intent is to reduce non-productive busy-work that has historically consumed the review process. Device submission review can often take many months, but there is an opportunity to reduce this timeframe and allow expert reviewers to focus on the more complex cases.Medical devices using AI are designed to analyze vast amounts of data to generate clinical insights. This means that the company’s quality management system (QMS) must ensure consistent production and control of manufacturing and quality systems, and involves routine inspections and audits.The Verifying Accurate Leading-Edge Development Act, or Valid Act, is pending and will codify the “firm-based” approach to regulation. The FDA will oversee methods used for technology development and validate reliability rather than decouple the AI product’s construction. By ensuring robust systems are in place, the FDA can enhance the overall safety and effectiveness of medical devices produced.Rapid cycles of innovation inherent in products due to constant modification based on new information available pose challenges. ChatGPT from OpenAI has demonstrated substantial semantic medical knowledge and the ability to perform work that will accelerate the submission approval process.Large Language Models (LLMs) trained on vast datasets embody the ultimate black box in the realm of FDA regulation. They are nonlinear and high-dimensional, making it difficult to trace specific inputs to outputs. A risk is that they may return wrong answers when trained on unreliable datasets. Under a firm-based regulation approach by the FDA, innovators can bring certain new products to market more efficiently.LLMs will boost efficiency, but input data must be quality-checked. Industry must develop adequate standards and controls, evaluating AI algorithm models under the specific intended use of a device. Ultimately, the industry will be able to identify new product candidates and plan, execute, and analyze data from clinical trials.In June 2025, the FDA announced plans to use AI to speed new medical device and SaMD approvals. Elsa is a tool that may enhance FDA review of safety data, summarize reports, and flag facilities needing inspection. Built within a high-security GovCloud environment, it offers a secure platform for FDA staff to access internal documents while ensuring information remains within the agency. Submission reviews could be considerably shortened.Learn more about how FDA and life science companies are using AI and ChatGPT. This is expected to improve efficiency while enabling the FDA and companies to run more smoothly. This is critical at a time when we are faced with a rising demand for healthcare and physician shortages. Leveraging comprehensive data systems will lead to greater efficiency in diagnosis and treatment planning. Getting these products through the FDA regulatory submission process more quickly and efficiently is the goal to put them in the hands of patients.For SaMD products, several guidance documents from the FDA and the International Medical Device Regulators Forum will be beneficial in understanding how to make changes to these products safely through a method using SaMD Pre-Specifications (SPS) and an Algorithm Change Protocol (ACP) to assess the potential risk and impact of a change.Learn about the FDA’s AI/ML SaMD Action Plan, encouraging harmonization among technology developers on the development of GMLP. This is part of the FDA’s mission to define new policies and enable innovation while protecting public health.You will also learn about the Total Product Lifecycle (TPLC) Approach for SaMD regulation. This is a new paradigm focused on the assessment of an organization in terms of its software design, development, testing, and monitoring activities. This is part of the FDA’s Software Pre-Certification (Pre-Cert) Program. In some cases, a new 510(k) may not be needed, and documentation of change and analysis of risk management can take its place.We’ll provide an overview of computer system validation, including the draft guidance from the FDA on Computer Software Assurance (CSA), and the latest GAMP®5, 2nd Edition, that aligns with CSA. We’ll walk you through the Software Validation and Maintenance approach that will bring clarity to what the FDA is looking for, primarily allowing companies to manage risks from changes, while enabling improvement of performance and advancing patient care.Learning Objectives - During the webinar, we will discuss the following:Learn about “GxP” operational areas, systems, and data regulated by the FDAUnderstand the basics of Computer System Validation (CSV), the traditional approachLearn about Computer Software Assurance (CSA) and how it compares with CSVKnow how to transition from CSV to CSA for validation of FDA-regulated systemsUnderstand the System Development Life Cycle (SDLC) Methodology for managing a system through all of its life phasesLearn about the concepts introduced in ISPE’s GAMP®5, 2nd Edition, and how these align with CSA principles of risk assessment and critical thinkingReview current trends in FDA 483s, Warning Letters, and Consent DecreesLearn about 21 CFR Part 11, FDA Guidance for Electronic Records and Electronic Signatures (ER/ES)Understand how Data Integrity (“ALCOA+” Principles) must be applied to FDA-regulated systemsKnow the key elements of a good Data Governance programLearn the phases of the Data LifecycleReview the key elements of Data Privacy laws (e.g., Health Information Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), California Privacy Rights Act (CPRA))Understand the importance of Audit Trails and Audit Trail ReviewKnow how to manage a validated system through User Authentication, Access Control, and Security MonitoringLearn about the industry Cost of Non-ComplianceUnderstand the deliverables for a Validation effort, starting with a Validation PlanKnow the key elements to include in an IT Vendor AuditUnderstand how to prepare solid Vendor Contracts and Service Level Agreements (SLAs)Learn how to develop a Requirements Specification (RS)Learn how to perform Risk Assessment, Risk Mitigation, and Risk-Based TestingUnderstand the advantages and key elements to consider when using Automated TestingKnow how to prepare an Installation Qualification (IQ) Test Protocol and Test Summary ReportKnow how to prepare an Operational Qualification (OQ) Test Protocol, Test Scripts, and Test Summary ReportLearn how to develop a Performance Qualification (PQ) Test Protocol, Test Scripts, and Test Summary ReportUnderstand the importance of a Requirements Traceability Matrix (RTM)Know how to write a Validation Summary ReportUnderstand the importance of a formal Change Control procedureKnow the key elements required for the maintenance of a System in a Validated StateKnow the advantages of using Commercial-Off-the-Shelf (COTS) Software and FDA expectations for validationLearn about Cloud-Based Services and the potential savings in ROI that can be generatedUnderstand the concepts of Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) environmentsKnow how to use the Single-Sign-On (SSO) capability to improve complianceUnderstand the need for a cloud-based service provider to have SOC 2 CertificationLearn about key concepts related to Artificial Intelligence (AI) and Machine Learning (ML)Understand how to use Large Language Models (LLMs) (e.g., ChatGPT, Gemini, Copilot)Learn about the FDA Directive to Leverage AI/ML Solutions in all agenciesKnow what is required to achieve FDA Inspection ReadinessLearn about Current Trends in FDA Inspection and EnforcementQ&AAreas Covered - During this webinar, the following areas will be covered:GxP SystemsGMP, GLP, GCPComputer System Validation (CSV)Computer Software Assurance (CSA)CSV to CSA TransitionGAMP®5, 2nd EditionFDA 483 ObservationsFDA Warning LettersFDA Consent Decrees21 CFR Part 11, FDA Guidance for Electronic Records and Electronic Signatures (ER/ES)Data Integrity (“ALCOA+” Principles)Data GovernanceData LifecycleData Privacy; Health Information Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), California Privacy Rights Act (CPRA)Audit Trails and Audit Trail ReviewUser Authentication, Access Control, and MonitoringSecurity MonitoringCost of Non-ComplianceValidation PlanVendor AuditVendor Contracts and Service Level Agreements (SLAs)Requirements Specification (RS)Risk Assessment and MitigationRisk-Based TestingCritical ThinkingAutomated TestingInstallation Qualification (IQ) Test Protocol and Test Summary ReportOperational Qualification (OQ) Test Protocol, Test Scripts, and Test Summary ReportPerformance Qualification (PQ) Test Protocol, Test Scripts, and Test Summary ReportRequirements Traceability Matrix (RTM)Validation Summary ReportChange ControlMaintenance of a System in a Validated StateCommercial-Off-the-Shelf (COTS) SoftwareCloud-Based ServicesSoftware-as-a-Service (SaaS)Infrastructure-as-a-Service (IaaS)Platform-as-a-Service (PaaS)Single-Sign-On (SSO)SOC 2 CertificationArtificial Intelligence (AI) and Machine Learning (ML)Large Language Models (LLMs) (e.g., ChatGPT, Gemini, Copilot)FDA Directive to Leverage AI/ML Solutions in AgenciesFDA Inspection ReadinessCurrent Trends in FDA Inspection and EnforcementIndustry Best PracticesBackground:In September 2025, the FDA issued a draft guidance for Computer Software Assurance (CSA). A final guidance was issued by the Agency in September 2025, but only for medical device companies and in the manufacturing and quality testing areas. The remainder of the life sciences industries must still adhere to the traditional Computer System Validation (CSV) approach to validating computer systems in FDA-regulated operations. In either case, companies can take advantage of some of the efficiencies related to following CSA, including risk-based testing and the use of critical thinking. We will discuss both CSV and CSA, comparing the two approaches, and will provide a pathway that can be taken to transition to CSA.The life science industries, including pharmaceutical, medical device, biotechnology, biological, and tobacco and tobacco-related products, continue to embrace new technology to improve the delivery of quality products in compliance with the FDA. In addition to some trends toward making use of cloud services, Software-as-a-Service (SaaS) solutions, and other technical innovations, that have more recently begun to be used more heavily in life science companies.Artificial Intelligence (AI) and Machine Learning (ML) are beginning to find a presence at these companies. While life science companies tend to lag behind other markets in using these technologies, they are catching up, and we are seeing much more activity related to AI use in software applications used to develop, produce, test, and manage life science products.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 environments where artificial intelligence (AI) and machine learning (ML) are becoming prevalent.The FDA became alarmed by the lack of compliance with data integrity and Part 11 requirements during the last decade. Out-of-compliance citations during this period, including Form 483s and Warning Letters, have skyrocketed for these key areas of compliance. But why?Based on discussions with clients and stakeholders at conferences and meetings, it has become obvious that most of the performers in the industry are under management pressure to do more work with fewer resources and in less time. This continues to lead performers to seek faster and easier ways to get the work done, and opens the door to more conversation around the use of AI/ML and ChatGPT in software development, testing, and support.It is time to embark on the AI/ML revolution and continue to deliver quality products in life sciences with compliance to meet the needs of the consumers by putting newer, more innovative, safer, and more effective products in their hands, all of which are key focus areas for the FDA. We will discuss how the FDA is using AI to provide a faster review of submissions and for some other purposes to support the industry.Why Should You Attend:Providing safe and effective medical device & SaMD products regulated by the FDA is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. You will learn about projects going on in the industry and at the FDA that take advantage of Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs), such as ChatGPT.With newer technologies such as AI in the mix, it means opportunity for greater efficiency and efficacy, but also poses more challenges for companies that develop, test, and support software applications in the life science industries.In this webinar, you will learn just how AI, ML, and LLMs, such as ChatGPT, can increase the efficiency and effectiveness of software development life cycle (SDLC) activities, enabling the delivery and support of computer solutions and new innovative medical device & SaMD products that will drive the industry over the coming years.This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, and tobacco. Applicable functions include regulatory affairs, regulatory submissions, research & development, manufacturing, Quality Control, distribution, clinical testing & management, adverse events management, and post-marketing surveillance.You should attend this webinar if you are responsible for planning, executing, or managing the development or implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.You should also attend this webinar if you are responsible for developing, testing, or supporting software used in medical device or SaMD products.Learn by reviewing industry best practices and knowing where to gather key information to help you move forward with these technologies quickly and in compliance with the FDA.Who Should Attend:This webinar is intended for those involved in planning, execution, and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco, and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Applicable functions include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management, and post-marketing surveillance.Personnel in the following roles will benefit:Information Technology (IT) AnalystsIT Software Developers & TestersIT Support StaffIT Security StaffQC/QA Managers and AnalystsProduction Managers and SupervisorsSupply Chain Managers and SupervisorsClinical Trial Data Managers and ScientistsCompliance Managers and AuditorsLab Managers and AnalystsComputer System Validation SpecialistsGMP, GLP, GCP Training SpecialistsBusiness Stakeholders using Computer Systems regulated by the FDARegulatory Affairs and Submissions PersonnelConsultants in the Life Sciences and Tobacco IndustriesInterns working at the companies listed aboveCollege students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA), or any other discipline that involves adherence to FDA regulatory requirementsPanel Speakers:Carolyn Troiano, has more than 40 years of experience in Computer System Validation (CSV) and compliance in the pharmaceutical, medical device, tobacco, and other FDA-regulated industries. She is currently an independent consultant advising companies on computer system validation and large-scale IT system implementation projects. She also delivers webinars and seminars on topics related to CSV, 21 CFR Part 11 (Electronic Records/Signatures), and data integrity compliance.Carolyn has worked in industry supporting CSV for most of her career and has adapted the ISPE GAMP5 “V” Model for use with an agile methodology for system development, testing, implementation, and support. Her approach is in line with the Computer Software Assurance (CSA) methodology that focuses on critical thinking rather than documentation, requiring us to shed our compliance blinders. Instead of asking what deliverables are needed, we should start by asking why we’re doing things in the first place and tempering our testing and validation accordingly, along with following a risk-based approach.&Meredith L. Crabtree, is a Regulatory Compliance and Quality Systems expert with over 30 years of hands-on experience in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, dietary supplements, cosmetics, and animal health products. She specializes in quality system development, regulatory strategy, auditing, and training, helping organizations navigate complex FDA, DEA, and ISO requirements. Meredith provides consulting services across life science industries, supporting clients with FDA inspection readiness, supplier audits, deviation management, CAPA programs, labeling compliance, and regulatory submissions.She is known for her practical, risk-based approach to quality management and her engaging, real-world training style. In addition to her consulting practice, Meredith serves as an accreditation inspector for the American Association of Tissue Banks (AATB) and is a frequent presenter on regulatory compliance topics. - **Event URL**: https://allevents.in/warren/master-csv-to-csa-ai-validation-and-inspection-readiness/100001988816830678 - **Event Categories**: workshops, science-fair, virtual, webinar, health-wellness, artificial-intelligence, trips-adventures, performances, entertainment, business, meetups, it - **Interested Audience**: - total_interested_count: 0 - **Event Highlights**: - Duration: 8 hours - Location: Somerset Hills Hotel, Tapestry Collection by Hilton - Languages: English ## Ticket Details - **Ticket Price Range**: min: 1699, max: 1699, 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**: Master CSV to CSA: AI validation and inspection readiness - **Image URL**: https://cdn-az.allevents.in/events6/banners/03b89d1f327e1a7e6b581f4d2d95ce7eea6fd32661c77249e6740b876cdbc67f-rimg-w1200-h600-dc413fe7-gmir.jpg?v=1778065224 ## FAQs - **Q**: When and where is Master CSV to CSA: AI validation and inspection readiness being held? - **A:** Master CSV to CSA: AI validation and inspection readiness takes place on Tue, 16 Jun, 2026 at 09:00 am to Wed, 17 Jun, 2026 at 05:00 pm at Somerset Hills Hotel, Tapestry Collection by Hilton, 200 Liberty Corner Road, Warren, United States. - **Q**: Who is organizing Master CSV to CSA: AI validation and inspection readiness? - **A:** Master CSV to CSA: AI validation and inspection readiness is organized by ConferencePanel. - **Q**: Who is this event for? Is it right for me? - **A:** Master CSV to CSA: AI validation and inspection readiness 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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