Dublin, Nov. 12, 2026 (GLOBE NEWSWIRE) -- "Computer System Validation Training Boot Camp? (Aug 19th - Aug 21st, 2026)" has been added to ResearchAndMarkets.com's offering.
Research and Markets has made the recording of “Computer System Validation Training Boot Camp” available for on-demand purchase.
Rapid advances in technology are prompting regulated organizations to reassess established business models, operating structures, and technology strategies. Healthcare and life sciences companies now operate in increasingly complex environments while serving patients and customers who have greater access to information and higher expectations for quality, responsiveness, and transparency. To remain effective and compliant, organizations must modernize their work practices, software development processes, and technology tools.
This seminar provides practical guidance for developing software, performing validation, and maintaining computerized systems in a validated state throughout the entire life cycle. Attendees will examine the factors that should be considered when selecting a development and validation methodology, particularly in environments subject to FDA oversight and data integrity requirements.
A central focus of the session is the comparison between agile and waterfall methodologies. The seminar evaluates the advantages, limitations, compliance implications, and operational considerations associated with each approach. Because no single methodology is appropriate for every organization, system, or regulated process, the discussion emphasizes risk-based decision-making and the importance of aligning development practices with intended use, system complexity, business needs, and applicable regulatory requirements.
The program also addresses major technology delivery models, including COTS, SaaS, IaaS, PaaS, and cloud services. Participants will review the potential benefits and risks associated with these options, with particular attention to vendor oversight, system control, validation responsibilities, security, data management, and ongoing compliance. The session is designed to help organizations evaluate whether selected hardware and software models can support business objectives while satisfying regulatory expectations.
Key areas covered during the seminar include:
- Software development and validation throughout the system life cycle
- Maintaining computerized systems in a validated state
- Agile and waterfall methodology comparisons
- Risk-based selection of development and validation approaches
- COTS, SaaS, IaaS, PaaS, and cloud service considerations
- FDA software validation expectations and current areas of concern
- 21 CFR Part 11 compliance, where applicable
- Data integrity controls and supporting documentation
- Technology vendor assessment and oversight
- Best practices for demonstrating sustained regulatory compliance
The seminar will examine current FDA concerns related to computerized systems and explain how organizations can prepare systems, processes, and documentation to meet regulatory expectations. Discussion will address the need for appropriate controls across development, implementation, operation, maintenance, and retirement activities. Participants will gain insight into how validation strategies can accommodate changing technologies without compromising system reliability, data integrity, or compliance.
Attendees will also learn how to identify gaps in existing practices and evaluate whether internal procedures remain suitable for modern technology environments. The content supports professionals responsible for software quality, computer system validation, regulatory compliance, information technology, quality assurance, data governance, and system ownership.
Optional exercises may be completed at each attendee's discretion. Both questions and answers are provided for every exercise, offering a total of 100 questions and answers. These materials reinforce the seminar content and allow participants to assess their understanding of software validation, FDA requirements, development methodologies, cloud services, 21 CFR Part 11, and data integrity expectations.
By combining regulatory insight with practical technology considerations, the seminar helps regulated organizations make informed decisions about software development, validation, and system maintenance. Participants will leave with a stronger framework for selecting appropriate methodologies, managing technology risks, and maintaining compliant computerized systems throughout their operational life cycle.
Who Should Attend:
Personnel in the following roles will benefit:
- Information Technology Analysts
- Information Technology Developers and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.
Key Topics Covered:
Day 1
Module 1: CSV Methods and Models
- GxP Systems
- Computer System Validation (CSV)
- Common SDLC Methodologies
- GAMP5 "V" Model
- Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
- Critical Thinking
- Waterfall vs. Agile Methodology
Module 2: Software and Services
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- Software 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 Devices
- Spreadsheet Validation
Module 3: CSV Planning
- Validation Plan
- Rationale for Validation Testing
- GAMP5 System Categorization
- Risk Assessment and Mitigation
Module 4: System Requirements and Design
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- System Design/Configuration Management Specification (SDS/CMS)
Day 1 Q&A Session
Day 2
Module 5: IQ, OQ, PQ Test Planning & Execution
- Validation Protocols - IQ, OQ, PQ
- Validation Test Execution
- Validation Test Summary Report
Module 6: Test and Validation Reports
- Requirements Traceability Matrix (RTM)
- Validation Summary Report
- System Acceptance and Release Notification
Module 7: CSV Operations and Maintenance
- Maintaining a System in a Validated State
- Disaster Recovery Planning
- Business Continuity Planning
- Incident Reporting, Investigation, and Remediation
- Record Retention
- System Retirement Challenges
- Legacy Systems and Integration
Module 8: CSV Supporting Components
- Good Documentation Practices (GDPs)
- Training
- Organizational Change Management (OCM)
- Validation Policies and Procedures
Day 3
Module 9: Managing FDA-Regulated Data
- 21 CFR Part 11 Guidance
- Electronic Records/Signatures (ER/ES) Requirements
- Data Integrity: ALCOA+ Principles
- Data Life Cycle Approach
- Data Governance
- Data Privacy: HIPAA, GDPRs, et al
Module 10: Vendor Audit
- Audit Preparation
- Audit Execution
- Post-Audit
- Vendor Contracts and Service Level Agreements (SLAs)
Module 11: FDA Trends
- Regulatory Influences
- Regulatory Trends
- Current Compliance and Enforcement Trends
Module 12: Inspection Preparation
- FDA Inspection Readiness
- Industry Best Practices
Day 3 Q&A Session
Module 13: CSV Exercises
- Exercise 1: CSV
- Exercise 2: Validation Plan (VMP) Writing
- Exercise 3: Risk Assessment
- Exercise 4: FDA Requirements for ER/ES
- Exercise 5: Interviews and URS/FRS Writing
- Exercise 6: IQ, OQ, PQ Test Protocol Writing
- Exercise 7: RTM Writing
- Exercise 8: Be the Consultant
Agenda
Day 1
Module 1: CSV Methods and Models
- GxP Systems
- Computer System Validation (CSV)
- Common SDLC Methodologies
- GAMP5 "V" Model
- Computer System Validation (CSV) vs. Computer Software Assurance (CSA)
- Critical Thinking
- Waterfall vs. Agile Methodology
Module 2: Software and Services
- Computer Off-the-Shelf (COTS) Software
- Cloud Systems
- Software 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 Devices
- Spreadsheet Validation
Module 3: CSV Planning
- Validation Plan
- Rationale for Validation Testing
- GAMP5 System Categorization
- Risk Assessment and Mitigation
Module 4: System Requirements and Design
- Requirements Development
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- System Design/Configuration Management Specification (SDS/CMS)
Day 1 Q&A Session
Day 2
Module 5: IQ, OQ, PQ Test Planning & Execution
- Validation Protocols - IQ, OQ, PQ
- Validation Test Execution
- Validation Test Summary Report
Module 6: Test and Validation Reports
- Requirements Traceability Matrix (RTM)
- Validation Summary Report
- System Acceptance and Release Notification
Module 7: CSV Operations and Maintenance
- Maintaining a System in a Validated State
- Disaster Recovery Planning
- Business Continuity Planning
- Incident Reporting, Investigation, and Remediation
- Record Retention
- System Retirement Challenges
- Legacy Systems and Integration
- Spreadsheet Validation
Module 8: CSV Supporting Components
- Good Documentation Practices (GDPs)
- Training
- Organizational Change Management (OCM)
- Validation Policies and Procedures
Day 3
Module 9: Managing FDA-Regulated Data
- 21 CFR Part 11 Guidance
- Electronic Records/Signatures (ER/ES) Requirements
- Data Integrity: ALCOA+ Principles
- Data Life Cycle Approach
- Data Governance
- Data Privacy: HIPAA, GDPRs, et al
Module 10: Vendor Audit
- Audit Preparation
- Audit Execution
- Post-Audit
- Vendor Contracts and Service Level Agreements (SLAs)
Module 11: FDA Trends
- Regulatory Influences
- Regulatory Trends
- Current Compliance and Enforcement Trends
Module 12: Inspection Preparation
- FDA Inspection Readiness
- Industry Best Practices
Day 3 Q&A Session
Module 13: CSV Exercises
- Exercise 1: CSV
- Exercise 2: Validation Plan (VMP) Writing
- Exercise 3: Risk Assessment
- Exercise 4: FDA Requirements for ER/ES
- Exercise 5: Interviews and URS/FRS Writing
- Exercise 6: IQ, OQ, PQ Test Protocol Writing
- Exercise 7: RTM Writing
- Exercise 8: Be the Consultant
Speakers:
Carolyn Troiano
For more information about this training visit https://www.researchandmarkets.com/r/1zgh3
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