Greetings!
The FDA’s February 2026 CSA guidance marks a major shift in how computerized systems are expected to be validated across pharmaceutical and regulated environments. The focus is no longer on excessive documentation for the sake of compliance, but on a smarter, risk-based approach centered around intended use, critical thinking, and modern software realities.
Join AAPS Pharma for an in-depth live webinar exploring how Computer Software Assurance (CSA) is reshaping traditional CSV practices, what this means for pharmaceutical and quality operations, and how organizations are expected to approach validation moving forward - including emerging applications involving AI and machine learning systems.
The session will be led by Mr. Ashish Kulkarni, a GMP and validation professional with 16+ years of hands-on pharmaceutical industry experience across operational readiness, facility startup, CQV, CSV, automation systems, and large-scale project execution within biotech and pharma environments. His experience spans Greenfield and Brownfield projects, risk-based validation methodologies, DeltaV, Syncade MES, Chronicle systems, and cross-functional implementation within regulated operations.
The workshop will cover: • FDA’s CSA Guidance and regulatory expectations • The shift from CSV to CSA and why the industry is changing • Risk-based validation and intended-use-focused assurance • Exploratory vs. scripted testing approaches • Practical implementation strategies and documentation examples • CSA applications within AI/ML systems and quality operations • Real-world pharmaceutical use cases and regulatory considerations
This session is designed for validation, quality, regulatory, and IT professionals working with GxP-regulated computerized systems, along with students and consultants pursuing careers in pharmaceutical compliance.
All participants will receive a certificate of attendance upon completion of the workshop. |
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