Training Agenda
From CSV to CSA: AI Validation, Data Integrity & FDA Inspection Readiness
Day 1: Building the Foundation for CSA & Digital Validation
Core CSA concepts, risk-based validation, data integrity, and right-sized documentation.
Session 1: Regulatory Landscape & Why CSA Matters
- FDA CSA Guidance and industry expectations
- Evolution from CSV to CSA
- GAMP® 5 Second Edition overview
- FDA 21 CFR Part 11
- Annex 11
- Data Integrity Guidance
- ICH Q9 & Q10
- Current inspection trends
- Common validation deficiencies cited by FDA
Session 2: Understanding Computer Software Assurance (CSA)
- CSA principles
- Critical Thinking approach
- Risk-Based Validation
- Assurance activities
- Software lifecycle under CSA
- Identifying high-risk functions
- When documentation can be reduced
- Transition strategy from CSV to CSA
Session 3: Risk Assessment & Critical Thinking
- System categorization
- Intended use
- Patient safety
- Product quality
- Data integrity risks
- Risk ranking methods
- FMEA
- Hazard Analysis
- Defining acceptance criteria
Session 4: Data Integrity Fundamentals
- ALCOA+
- Audit Trails
- Electronic Records
- Electronic Signatures
- Metadata
- Backup & Disaster Recovery
- Cloud systems
- Hybrid environments
- Common FDA observations
Session 5: CSA Documentation
- Validation Planning
- User Requirements
- Risk Assessment
- Test Strategy
- Traceability
- Summary Reports
- Leveraging vendor documentation
- Right-sizing documentation
Day 2: AI Validation, Inspection Readiness & Practical Implementation
AI/ML validation, cloud compliance, vendor qualification, inspection strategy, and CSA implementation planning.
Session 6: Artificial Intelligence & Machine Learning Validation
- AI in regulated environments
- FDA expectations
- AI governance
- Large Language Models (LLMs)
- Generative AI risks
- Model lifecycle
- Bias
- Explainability
- Continuous learning systems
- AI Change Control
Session 7: Validating AI & Software Applications
- AI Risk Assessment
- Validation strategy
- Testing AI outputs
- Training datasets
- Performance qualification
- Drift monitoring
- Revalidation
- Supplier documentation
Session 8: Vendor Qualification & Cloud Compliance
- SaaS validation
- Supplier qualification
- Vendor audits
- Service Level Agreements
- Cybersecurity considerations
- Shared responsibility model
- Third-party software documentation
Session 9: FDA Inspection Readiness
- Preparing validation packages
- Inspection strategy
- Responding to investigator questions
- Documentation expectations
- Mock FDA interview
- Common FDA 483 observations
- Best practices for inspection success
Session 10: Implementation Roadmap
- Building a CSA Program
- Governance structure
- SOP updates
- Team responsibilities
- Metrics & KPIs
- Change Management
- Organizational readiness
- Continuous improvement roadmap
Interactive Workshops Included
Course Description
Organizations can begin applying many Computer Software Assurance (CSA) principles today, even outside the current scope of the FDA's final guidance. This is possible provided they can adequately explain and defend their approach in relation to 21 CFR Part 11, Data Integrity, the Quality Management System (QMS), Computer System Validation (CSV) requirements, and other applicable regulatory documents, quality programs, and industry best practices.
In this CSV to CSA Training Seminar, participants will receive a practical overview of the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). The seminar provides a step-by-step guide to implementing the transition within any FDA-regulated organization. Each transition step, required documentation, validation deliverables, supporting artifacts, and potential implementation challenges will be explained in detail to help organizations successfully adopt a risk-based CSA approach.
The seminar includes an interactive Q&A session at the end of each day, allowing participants to discuss real-world validation challenges and CSA implementation strategies. The course materials also include comprehensive appendices containing regulatory references and supporting resources related to FDA CSA Guidance, GAMP® 5, Data Integrity, and computerized system validation, which participants can review after the seminar. In addition, attendees will receive review questions with detailed answers and explanations to reinforce learning and support the successful implementation of Computer Software Assurance (CSA) within their organizations.
Who Will Benefit
This Computer Software Assurance (CSA) and Computer System Validation (CSV) training is designed for professionals involved in computerized systems, software validation, quality assurance, regulatory compliance, data integrity, and Quality Management Systems (QMS) in pharmaceutical, biotechnology, medical device, and other FDA-regulated industries.
The course is ideal for:
- Information Technology (IT) Analysts, Developers, and Testers
- Software Quality Assurance (SQA) Professionals
- Quality Assurance (QA) and Quality Control (QC) Managers and Analysts
- Computer System Validation (CSV) and Computer Software Assurance (CSA) Specialists
- Validation Engineers and Automation Professionals
- Analytical Chemists and Laboratory Managers
- Compliance, Audit, and Risk Management Professionals
- Manufacturing and Supply Chain Managers
- Regulatory Affairs and Regulatory Submissions Specialists
- Clinical Data Analysts, Clinical Data Managers, and Clinical Trial Sponsors
- GMP Training Specialists
Why Should You Attend
Providing safe and effective pharmaceuticals, medical devices, and other FDA-regulated products is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products, as well as the customers/patients. You will learn about the FDA's Computer System Validation (CSV) and Computer Software Assurance (CSA) approaches, where the latter enables practitioners to take advantage of newer technologies and innovations, including cloud services and Software-as-a-Service (SaaS) solutions. Computer Software Assurance (CSA) provides a more practical, risk-based approach to testing and verification of requirements based on the potential risk should they fail to operate properly. It is no longer a "one-size-fits-all" testing approach, as taken with traditional Computer System Validation (CSV). CSA is also focused on critical thinking and requires some organizational change management to fully implement it within your environment.
In this seminar, you will learn how to transition your validation work from classic Computer System Validation (CSV) to Computer Software Assurance (CSA), based on the FDA's 2022 draft guidance and the final guidance issued in September 2025 for medical device companies, specifically in the areas of manufacturing and quality testing. You can increase the efficiency and effectiveness of Software Development Life Cycle (SDLC) activities, enabling the delivery and support of computerized systems, software solutions, and new innovative products that will drive the industry over the coming years.
You will also learn about 21 CFR Part 11 (Electronic Records/Electronic Signatures - ER/ES), Data Integrity, data lifecycle management, and data privacy, while following a Computer Software Assurance (CSA) approach to validation.
Finally, we will cover industry and FDA trends related to the use of Artificial Intelligence (AI), Machine Learning (ML), and Large Language Models (LLMs), such as ChatGPT, Copilot, and Gemini. Both industry and the FDA have begun work in this area, which is currently under review to determine the appropriate regulatory framework to apply.
This seminar is intended for those working in FDA-regulated industries, focused specifically on medical device companies. However, Computer Software Assurance (CSA) principles can also be applied to pharmaceutical, medical device software, and tobacco products, provided they are implemented carefully with documented, defensible evidence.
You should attend this seminar if you are responsible for planning, executing, or managing the development, implementation, or validation of any computerized system governed by FDA regulations, or if you are using, maintaining, or supporting such a system. Learn industry best practices and where to gather key information to help you move forward with Computer Software Assurance (CSA), Computer System Validation (CSV), and newer technologies quickly and in compliance with FDA requirements.
Faculty Carolyn Troiano
RiskCortex Compliance & Quality Authority Lead/ Advisor
( 45 + yrs exp.)
Carolyn Troiano has 45+ years of experience in computer system validation in the FDA-regulated industries. She is a consultant advising clients on best industry practices for delivering quality and compliant solutions that incorporate newer technologies.
Carolyn participated in the FDA/industry partnership that developed 21 CFR Part 11.
Carolyn encourages leveraging newer technologies and approaches to validation using Computer Software Assurance (CSA) principles.
Carolyn has spoken at international conferences on validation, Part 11, and data integrity.
