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.
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.
Course Content
Day 1: Building the Foundation for CSA & Digital Validation
Session 1: Regulatory Landscape & Why CSA Matters
Session 2: Understanding Computer Software Assurance (CSA)
Session 3: Risk Assessment & Critical Thinking
Session 4: Data Integrity Fundamentals
Session 5: CSA Documentation
Day 2: AI Validation, Inspection Readiness & Practical Implementation
Session 6: Artificial Intelligence & Machine Learning Validation
Session 7: Validating AI & Software Applications
Session 8: Vendor Qualification & Cloud Compliance
Session 9: FDA Inspection Readiness
Session 10: Implementation Roadmap
Speaker
Carolyn TroianoWho Should Attend
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
