Implementing CSA for GxP Systems - Transition, Documentation,

The FDA’s Shift from CSV to CSA is Here – Are You Prepared?

💡 Do you understand how CSA will impact your validation processes?

💡 Are you prepared for post-transition compliance challenges?

💡 Want expert insights on risk-based approaches and automation?

This seminar will answer all your questions.

Meet Your Expert: Carolyn Troiano 🔹 30+ years of expertise in FDA-regulated industries
🔹 Worked directly with FDA & industry leaders on CSV & CSA compliance
🔹 Helped shape validation strategies since the 1980s
🔹 Recognized thought leader & speaker at industry conferences
Carolyn has led large-scale IT validation projects for major pharma, medical device, and biotech companies across the US and Europe. She has also contributed to regulatory initiatives like 21 CFR Part 11 and actively supports project management education for non-profits.

AGENDA
DAY 1 (10 AM - 3 PM EST) Introduction to CSA and its regulatory significance CSV vs. CSA – Understanding the shift Agile & Waterfall methodologies for validation Risk-based validation principles & documentation strategies CSA implementation for Cloud-based, SaaS & COTS systems Establishing policies & procedures for CSA adoption Live Q&A Session		DAY 2 (10 AM - 3 PM EST) Addressing post-transition compliance challenges Continuous validation & automated testing best practices Risk assessments & prioritization strategies for GxP systems Vendor audits & supplier compliance assessments Preparing for FDA inspections & communicating CSA strategies Real-world case studies showcasing successful CSA transitions Interactive Q&A Session

The transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) is a game-changer for FDA-regulated industries. Are you ready to adopt risk-based validation strategies, leverage automation, and ensure compliance while reducing validation costs?

This intensive two-day seminar will guide you through the strategic and technical aspects of implementing CSA for GxP systems. You'll learn how to seamlessly transition from traditional CSV methods, integrate CSA into your Quality Management System (QMS), and tackle post-transition challenges like data integrity, vendor audits, and regulatory compliance.

Join Carolyn Troiano, a 30+ year industry expert who has helped shape FDA validation practices, as she walks you through CSA implementation step by step—with real-world case studies, documentation strategies, and interactive Q&A sessions.

WHAT YOU'LL LEARN IN THIS SEMINAR

✅ How CSA Differs from CSV – The key shifts in methodology and compliance expectations
✅ Risk-Based Validation – How to prioritize risks for smarter, streamlined assurance
✅ Agile vs. Waterfall Approaches – Which validation method fits your GxP system?
✅ Data Integrity & FDA Expectations – How to meet compliance without overburdening resources
✅ Automated Testing & Continuous Validation – Practical techniques to enhance efficiency
✅ Post-Transition Challenges & Opportunities – How to maintain compliance in the long run
✅ Vendor Audits & Supplier Assessments – What to look for to ensure CSA compliance

WHO SHOULD ATTEND

If you're involved in computer system validation, compliance, or IT management within an FDA-regulated industry, this seminar is for you!

👩‍💻 IT, QA & Business Managers – Oversee or participate in validation projects

📊 Regulatory & Compliance Experts – Align validation strategies with FDA expectations

🛠 Manufacturing & Automation Professionals – Implement CSA in production environments

🔬 Clinical & Research Teams – Ensure GxP compliance in software and data systems

💼 Supply Chain & Vendor Managers – Conduct CSA-ready supplier audits

Applicable industries:

Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities