Digital enabled Validation & Compliance: From Documents to Decisions
In the highly regulated world of life sciences, compliance is not just a regulatory mandate; it’s a direct link to patient safety, drug quality, and organizational trust - it’s a lifeline. For decades, pharmaceutical companies have relied on traditional Computer System Validation (CSV) to demonstrate regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, and GxP requirements.
However, as regulations evolve and digital portfolios expand, traditional CSV and compliance monitoring will be replaced with more risk-based approaches supported by continuous audit readiness frameworks.
Join our expert panel to hear their views and journey of AI infused Validation & Compliance Monitoring. The session will focus on the latest regulatory policies, AI approaches, and Tools/ Accelerators adopted by Industry for Automated Validation & Compliance.
Speakers
Sachin Bhandari
Head of Quality Digital Industrialization
UCB
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Carolyn Troiano
Founder, FDA Compliance Advisor
Brainstorm Central Consulting
Aji Karunan
Vice President, Asia Pacific
Valgenesis
Munish Sharma
Head of Computer Systems Validation
Arcolab
Kelli L. Bravo
Vice President, Healthcare and Life Sciences
Coforge
Key Takeaways
- Insights from Industry Experts on the latest trends and policies impacting Validation & Compliance
- How are Pharmaceutical, Biotechnology, Medical Device organizations planning this journey?
- AI / Automation journey and roadmap, while addressing organization, cultural and governance challenges / considerations