Conference Panel

As FDA-regulated industries embrace digital transformation, organizations face increasing pressure to ensure data integrity, validate AI-driven systems, implement Computer Software Assurance (CSA), and maintain inspection readiness.

Join industry experts Carolyn Troiano and Meredith Crabtree for a comprehensive 2-Day In-Person Seminar:
🔹 From CSV to CSA: Practical Strategies for Data Integrity, Artificial Intelligence (AI) Validation, and Inspection Readiness

📅 June 16–17, 2026
⏰ 9:00 AM – 5:00 PM EST
📍 Piscataway, New Jersey

This intensive seminar goes beyond theory and delivers practical, real-world strategies for:
✅ Transitioning from traditional Computer System Validation (CSV) to CSA
✅ Implementing risk-based validation and critical thinking approaches
✅ Ensuring compliance with 21 CFR Part 11 and ALCOA++ data integrity principles
✅ Managing data governance, privacy, and lifecycle requirements
✅ Validating AI/ML systems and understanding FDA expectations
✅ Preparing for FDA inspections and addressing common compliance gaps
✅ Leveraging GAMP®5 (2nd Edition) principles for modern validation programs

Through real FDA enforcement examples, case studies, interactive exercises, and hands-on discussions, attendees will gain actionable tools that can be immediately applied within their organizations.

🎤 Featured Speakers

Carolyn Troiano – A recognized compliance expert with over 45 years of experience in pharmaceutical, medical device, to***co, and other FDA-regulated industries. Carolyn specializes in CSV, CSA, SDLC methodologies, GAMP®5, 21 CFR Part 11, Data Integrity, and Data Privacy.

Meredith Crabtree – Regulatory consultant with over 30 years of experience across pharmaceuticals, medical devices, blood, tissue, laboratory, cosmetics, supplements, and animal health industries, specializing in inspections, regulatory assessments, recalls, labeling, and quality systems.

This seminar is ideal for professionals in Quality, Compliance, Validation, IT, Regulatory Affairs, Manufacturing, Clinical Operations, and anyone responsible for FDA-regulated systems and processes.

📌 Register Now, https://lnkd.in/gufBv5Xv

Secure your seat today and gain the practical knowledge needed to navigate the future of compliance, AI validation, and inspection readiness.

🌎 Happy World Environment Day! 🌿

Today is a reminder that the choices we make—big or small—can have a lasting impact on our planet. By embracing sustainable practices, conserving resources, and caring for the environment, we can help create a healthier and greener future for generations to come.

Let's work together to protect the Earth we all share and inspire positive change in our communities every day.

Wishing everyone a meaningful and inspiring World Environment Day!

🌱 One Planet. One Future. One Responsibility. 🌱

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