Pharma & Biotech Computerized Systems Validation, Data Integrity & Cloud Computing Training Seminar (Dec 9th - Dec 10th, 2025)

Dublin, Nov. 07, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 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 webinar 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.

Why should you attend

The attendee will learn about how to take advantage of modern, evolving technology while remaining compliant with FDA regulations related to computer systems and data. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, including automated testing tools that will result in a continuous validation of software products. The CSA approach is risk-based and relies heavily on critical thinking. It is aligned with GAMP5, Second Edition, published in July 2022. We will discuss the pros and cons of various approaches, and industry best practices for success.

The attendee will learn how to validate systems to meet 21 CFR Part 11, and data integrity compliance. We will touch on compliance with data privacy laws, including HIPAA, GDPRs, and other privacy regulations.

We will cover Computer-Off-the-Shelf (COTS) software, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services. You'll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.

We will also address spreadsheet validation. While tools like MS Excel, Google Sheets, and others do not have to be validated if used out-of-the-box without any customization. However, if you include macros or any type of customization, it will need to be validated. Learn about a streamlined approach to get a handle on the plethora of spreadsheets that are used across your organization for FDA-regulated data.

This seminar will be in-person, providing ample time for greater audience interaction. Bring your most pressing questions, describe you "pain points," and learn how to solve some of the most confounding issues related to validation.

Areas Covered

Learn how to identify "GxP" SystemsLearn about FDA's current thinking about technology and software development, and how this will impact industryDiscuss the current state of Computer System Validation (CSV) approach based on FDA requirementsLearn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validationLearn about cloud services and cloud service providers to optimize your experienceLearn ways to validate in the cloud without compromising quality or complianceLearn the pros and cons of an agile vs. waterfall approachWe will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectivelyDiscuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentationUnderstand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but are in the cloudUnderstand how to maintain a system in a validated state through the system's entire life cycle in a more cost-effective manner, applying an agile continuous validation approachLearn how to assure the integrity of data that supports GxP work, despite changes and advances in new technologyDiscuss the importance of "GxP" documentation that complies with FDA requirementsLearn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated stateKnow the regulatory influences that lead to FDA's current thinking at any given timeLearn about current trends in FDA compliance and enforcementFinally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycleQ&A

12.0 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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

2 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:

Personnel in the following roles will benefit:

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 maintenance

Key Topics Covered:

Day 1:

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 Notification

Day 1 Q&A Session

Day 2:

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

Day 2 Q&A Session

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

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/axoevc

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.