Online Computer System Validation (CSV/CSA) Course: Navigating Changing Landscapes – 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems

DUBLIN, Oct. 27, 2023 /PRNewswire/ — The “Computer System Validation (CSV/CSA), 21 CFR Part 11, Data Integrity/Privacy Compliance for FDA-Regulated Systems” training has been added to ResearchAndMarkets.com’s offering.

In today’s fast-evolving technological landscape, organizations face the imperative to reevaluate their business models. What were once structured and predictable operations are now characterized by complexity and unpredictability. Patients and customers are more informed and hold higher expectations than ever before. As such, work practices and tools must adapt to meet these evolving challenges head-on.

Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment. This session will offer a comprehensive comparison of agile and waterfall methodologies, highlighting their respective advantages and disadvantages. Recognizing that a one-size-fits-all approach may not be suitable, this webinar will guide you in making informed decisions when choosing the right methodology.

Additionally, we will delve into the world of Commercial Off-The-Shelf (COTS) solutions, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services, uncovering the benefits and risks associated with each model. Throughout the discussion on hardware and software options, we will emphasize best practices for aligning with FDA requirements for validation, including compliance with 21 CFR Part 11 and data integrity standards.

This session will also shed light on the FDA’s current areas of concern and how to ensure that your systems meet their expectations.

Key Takeaways:

Learn how to leverage modern technology while remaining compliant with FDA regulations for computer systems and data.Explore the modernization of the System Development Life Cycle (SDLC) with an agile approach, in alignment with FDA’s draft guidance for Computer Software Assurance (CSA).Understand the pros and cons of different validation approaches and industry best practices for success.Gain insights into validating systems to meet 21 CFR Part 11 and data integrity compliance.Navigate the complexities of compliance with data privacy laws, including HIPAA, GDPR, and other privacy regulations.Get an overview of spreadsheet validation and streamline the validation process for commonly used tools like MS Excel and Google Sheets.

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

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 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 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/imrd9w

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