The regulatory landscape has shifted from documentation-heavy Computer System Validation (CSV) toward risk-based Computer Software Assurance (CSA), placing greater emphasis on critical thinking, intended use, patient safety, product quality, and evidence-based decision-making. Organizations must now demonstrate not only that systems are validated, but that validation decisions are scientifically justified, risk-based, and defensible during inspections.
This intensive two-day course provides a practical framework for applying CSV, CSA, GAMP® 5 principles, and quality risk management to modern GxP systems, including cloud, SaaS, configurable, and AI-enabled platforms. Attendees will learn how to determine the appropriate level of validation effort, focus testing where it matters most, leverage vendor documentation appropriately, and maintain systems in a continuous state of compliance. The course emphasizes inspection readiness, practical application, and regulatory-defensible decisions rather than excessive documentation.
| LEARNING OBJECTIVES
- Understand what FDA's CSA approach means in practice and how it differs from traditional CSV.
- Learn how to apply risk-based thinking to reduce unnecessary validation activities while maintaining compliance.
- Gain confidence in making and defending validation decisions during inspections and audits.
- Discover practical methods for validating cloud, SaaS, configurable, and AI-enabled systems.
- Improve validation efficiency by focusing resources on functions that impact patient safety, product quality, and data integrity.
- Learn how to leverage supplier documentation without compromising regulatory expectations.
- Develop inspection-ready validation strategies that withstand FDA, EMA, MHRA, and customer scrutiny.
- Strengthen your understanding of GAMP® 5, CSA, data integrity, and modern validation best practices.
- Participate in hands-on exercises that demonstrate how to apply risk-based validation concepts to real-world GxP systems.
- Leave with practical tools, templates, and decision-making frameworks that can be immediately applied within your organization.
| | COURSE AGENDA |
|
|
|
| DAY 1: Foundations of Modern CSV and CSA |
| DAY 2: Defensible Validation Decisions in Practice |
|
| - Evolution from traditional CSV to FDA's CSA approach
- Regulatory expectations for computerized systems in GxP environments
- Understanding intended use and fitness for purpose
- Applying critical thinking to validation activities
- Risk-based validation principles and testing strategies
- GAMP® 5 and GAMP® 5 2nd Edition concepts
- Determining system criticality, complexity, and risk
- Validation planning and rationale development
- Requirements management and traceability
- Leveraging supplier assessments and vendor documentation
- Validation approaches for SaaS, cloud, and configurable systems
- Inspection expectations and common validation deficiencies
|
| - Applying CSA to modern software development approaches
- Agile, DevOps, and continuous deployment considerations
- Risk-based testing: unscripted, scripted, and exploratory testing
- Validation of AI-enabled and machine learning systems
- Data integrity and 21 CFR Part 11 considerations
- Using risk assessments to justify validation scope and effort
- Change control and maintaining the validated state
- Audit trail review and documentation strategies
- Building an inspection-ready validation package
- Defending validation decisions during regulatory inspections
- Real-world case studies and validation decision exercises
- Practical frameworks for reducing validation effort while maintaining compliance
|
|
|
|
|
|
|
| WHO SHOULD ATTEND
- Quality Assurance Departments
- Validation and CSV Practitioners
- IT and Digital Transformation Leaders
- System Owners
- Data Integrity Specialists
- Compliance Departments
- AI Governance Teams
- Regulatory Affairs Departments
- Everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems.
- This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance. It will also help those in software development companies who support the life science industries.
Course Director: Carolyn Troiano
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA’s Guidance for Electronic Records and Electronic Signatures. During her career she has provided consulting and training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.