2 Day Computer System Validation Training Boot Camp: Master FDA, EMA, and GAMP 5 Computer System Validation Requirements (Online Course: Dec 9th - Dec 11th, 2025)

Dublin, Nov. 10, 2025 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Boot Camp?: Master FDA, EMA, and GAMP 5 Computer System Validation Requirements (Dec 9th - Dec 11th, 2025)" training has been added to ResearchAndMarkets.com's offering.

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This seminar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

We'll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we'll include the best practices for meeting FDA's requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA's current concerns and how to ensure your systems will meet their expectations.

This live training webinar includes the following for each registered attendee:

3-Day CSV Training SessionA copy of the presentation slides by downloadA certificate of participation for attendee training recordsQ/A SessionFree Handouts on CSV

Who Should Attend:

Information Technology AnalystsInformation Technology Developers and TestersSoftware Quality Assurance ProfessionalsQC/QA Managers and AnalystsAnalytical ChemistsCompliance and Audit ManagersLaboratory ManagersAutomation AnalystsManufacturing Specialists and ManagersSupply Chain Specialists and ManagersRegulatory Affairs SpecialistsRegulatory Submissions SpecialistsRisk Management ProfessionalsClinical Data AnalystsClinical Data ManagersClinical Trial SponsorsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter ExpertsBusiness System/Application TestersVendors responsible for software development, testing and maintenanceVendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Key Topics Covered:

Module 1: CSV Methods and Models

GxP SystemsComputer System Validation (CSV)Common SDLC MethodologiesGAMP5 "V" ModelComputer System Validation (CSV) vs. Computer Software Assurance (CSA)Critical ThinkingWaterfall vs. Agile Methodology

Module 2: Software and Services

Computer Off-the-Shelf (COTS) SoftwareCloud SystemsSoftware as a Service (SaaS)Platform as a Service (PaaS) & Infrastructure as a Service (IaaS)Single Sign On (SSO)Medical Devices using Software.Software-as-a-Medical Device (SaaMD)Mobile DevicesSpreadsheet Validation

Module 3: CSV Planning

Validation PlanRationale for Validation TestingGAMP5 System CategorizationRisk Assessment and Mitigation

Module 4: System Requirements and Design

Requirements DevelopmentUser Requirements Specification (URS)Functional Requirements Specification (FRS)System Design/Configuration Management Specification (SDS/CMS)

Module 5: IQ, OQ, PQ Test Planning & Execution

Validation Protocols - IQ, OQ, PQValidation Test ExecutionValidation Test Summary Report

Module 6: Test and Validation Reports

Requirements Traceability Matrix (RTM)Validation Summary ReportSystem Acceptance and Release NotificationDay 1 Q&A Session

Module 7: CSV Operations and Maintenance

Maintaining a System in a Validated StateDisaster Recovery PlanningBusiness Continuity PlanningIncident Reporting, Investigation, and RemediationRecord RetentionSystem Retirement ChallengesLegacy Systems and IntegrationSpreadsheet Validation

Module 8: CSV Supporting Components

Good Documentation Practices (GDPs)TrainingOrganizational Change Management (OCM)Validation Policies and Procedures

Module 9: Managing FDA-Regulated Data

21 CFR Part 11 GuidanceElectronic Records/Signatures (ER/ES) RequirementsData Integrity: ALCOA+ PrinciplesData Life Cycle ApproachData GovernanceData Privacy: HIPAA, GDPRs, et al

Module 10: Vendor Audit

Audit PreparationAudit ExecutionPost-AuditVendor Contracts and Service Level Agreements (SLAs)

Module 11: FDA Trends

Regulatory InfluencesRegulatory TrendsCurrent Compliance and Enforcement Trends

Module 12: Inspection Preparation

FDA Inspection ReadinessIndustry Best Practices

Module 13: CSV Exercises

Exercise 1: CSVExercise 2: Validation Plan (VMP) WritingExercise 3: Risk AssessmentExercise 4: FDA Requirements for ER/ESExercise 5: Interviews and URS/FRS WritingExercise 6: IQ, OQ, PQ Test Protocol WritingExercise 7: RTM WritingExercise 8: Be the Consultant

Q&A Session

Speakers:

Carolyn Troiano
Webinar/Seminar/Workshop Instructor in FDA Compliance Training

Carolyn Troiano has more than 35 years of experience 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, developing and executing compliance strategies and programs

For more information about this training visit https://www.researchandmarkets.com/r/xez72b

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