Project Management for CSV in FDA-Regulated Environments (CSA, GAMP®5 2nd Ed.) — with a Brief AI/ChatGPT Overview for PM Support

Overview:

Computer System Validation (CSV) has underpinned FDA compliance in regulated industries for decades. This session explains how to manage CSV as a disciplined project, aligning the five phases—Planning, Development, Implementation, Operations & Maintenance, and Retirement—with a practical System Development Life Cycle (SDLC) so systems can be placed into, and maintained in, a validated state.

We begin with the regulatory foundation: 21 CFR Part 11 for electronic records and electronic signatures (ER/ES) and FDA’s sustained emphasis on data integrity across the entire data lifecycle. Attendees will see how these expectations apply to all systems that “touch” product—from creation and collection to analysis, management, transfer, and reporting—and how integrity must be preserved for both structured data (e.g., databases) and unstructured data (e.g., documents, spreadsheets, presentations, images, audio, video).

From there, we outline a risk-based validation approach consistent with FDA’s Computer Software Assurance (CSA) thinking and updates in GAMP®5, 2nd Edition. The session explains how system size, complexity, business criticality, GAMP®5 category, and risk rating shape the scope and rigor of testing. We will discuss how risk is evaluated—considering probability, severity, detectability, and available mitigations—with attention to potential impact on data integrity, process and product quality, and patient/consumer safety.

Because many environments now rely on external platforms, we address cloud services and Software-as-a-Service (SaaS): what to expect in vendor audits, how to approach Installation Qualification (IQ) when providers host infrastructure, and how these realities affect planning, documentation, and ongoing control. We also touch on how evolving development practices—such as agile, AI, and machine learning—fit within validation expectations without compromising compliance.

Throughout the session, we connect project management concepts to day-to-day validation work—planning, developing, implementing, executing, documenting, and sustaining controls—so teams understand how to coordinate activities and responsibilities across the lifecycle. Finally, we provide an overview of how AI/LLMs (including ChatGPT) may assist with information gathering, documentation, and communication within a project management framework, while maintaining appropriate boundaries to support FDA compliance.

A concluding discussion of industry best practices ties these elements together so attendees can align project management, risk assessment, and regulatory expectations in their CSV efforts. Q&A will follow.

Areas covered in the session:

• Understand the Computer System Validation (CSV) approach aligned with FDA requirements.
• Learn what Computer Software Assurance (CSA) is and how this risk-based approach can streamline validation work.
• Review the differences introduced by ISPE in GAMP®5, 2nd Edition (July 2022).
• Learn best practices for working with cloud services and SaaS providers, including how to conduct vendor audits and perform Installation Qualification (IQ) for validation.
• Follow the System Development Life Cycle (SDLC) approach to software development, testing, and release, including the use of automated testing to streamline activities—particularly for updates.
• Document computer system validation efforts effectively, including requirements, design, development, testing, and operational maintenance procedures.
• Assess a system’s size, complexity, business criticality, GAMP®5 category, and risk (should it fail) to develop a cohesive and comprehensive validation rationale.
• Apply a project-management approach to plan, develop, implement, execute, and document validation activities.
• Maintain the system in a validated state throughout its life cycle once validation is complete.
• Gain an overview of AI and ChatGPT and how they can assist with information gathering, documentation, and communication to help keep projects on track.
• Understand industry best practices that optimize validation and compliance based on project management, risk assessment, and the appropriate use of AI/ChatGPT.
• Q&A.

Handouts:

Attendees will receive exclusive access to presentation materials provided by the speaker, along with specially developed resources created by Amorit Education to support your team’s post-session implementation. These materials are available only to registered attendees of this webinar and cannot be found or accessed through any other venue.

Why should you attend?

If you manage or support validation in an FDA-regulated environment, this session shows how to run Computer System Validation as a disciplined project—mapping the five phases (planning through retirement) to a practical SDLC so you can place systems into, and keep them in, a validated state. Expect clear connections between project tasks and day-to-day validation deliverables.

You’ll get a grounded walkthrough of the risk-based approach regulators expect today—how CSA thinking and GAMP®5 (2nd Edition) shape scope and testing depth—plus where 21 CFR Part 11 and data integrity requirements apply across structured and unstructured data. We’ll also address what changes when your environment includes cloud/SaaS and how to approach vendor audits and IQ with hosted providers.

Finally, you’ll see an overview of where AI/LLMs (including ChatGPT) can assist with information gathering, documentation, and communication within a project management framework—alongside the human review and controls needed to stay within FDA expectations. No hype—just practical alignment of project management, risk, and compliance.

Industries that benefit from this training:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

• Pharmaceutical
• Medical Device
• Software Companies Developing Medical Device Software and/or Software-as-a-Medical-Device (SaMD)
• Software vendors providing products & services to FDA-regulated industries
• Biologicals
• Tobacco
• E-Liquid/Vapor
• E-Cigarette
• Cigar
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Professionals responsible for planning, executing, documenting, or maintaining Computer System Validation (CSV) in FDA-regulated environments—and leaders who oversee data integrity, SDLC, cloud/SaaS qualification, or Part 11 activities—will benefit from this session; those include:

• Project Managers / PMO (CSV/IT/GxP)
• Computer System Validation (CSV) Leads / Engineers / Specialists
• Computer Software Assurance (CSA) Practitioners
• Quality Assurance (QA) Managers / Specialists (GxP)
• Quality Systems / Compliance Managers
• Data Integrity Leads / Specialists
• Validation / Qualification Managers (IQ/OQ/PQ)
• GxP System Owners / Business Process Owners
• IT / IS Managers supporting GxP systems
• SDLC / Software Development Managers
• Test / Validation Engineers; Automation Test Engineers
• Change Control / Release Management Leads
• Documentation / Technical Writers (GxP)
• Regulatory Affairs Associates / Managers
• Clinical QA / GMP QA / GLP QA Professionals
• Manufacturing / Operations Managers (regulated environments)
• Laboratory Managers / LIMS Administrators
• Cloud / SaaS Governance & Vendor Management Leads
• Auditors (Internal, Supplier, Computerized Systems)
• Consultants in CSV/CSA, Part 11, and Data Integrity