* Download the : Registration Form
Day 1- From CSV to CSA, Part 1: GAMP®5 Alignment, 21 CFR Part 11, and Data Integrity Fundamentals
Part 1 of this two-part series lays the groundwork for the industry’s move from Computer System Validation (CSV) toward Computer Software Assurance (CSA). It reviews the classic CSV approach and the GAMP®5 “V” Model, walks through validation planning, requirements, testing, reporting, and traceability, and introduces the CSA approach and its emphasis on critical thinking, along with how GAMP®5, 2nd Edition aligns with it.
The session also covers 21 CFR Part 11 electronic records/electronic signature (ER/ES) requirements and controls, common deficiencies cited during FDA inspections, and then turns to data integrity: core requirements and controls, common deficiencies, data life cycle management, data governance, and data privacy.
Note that CSA reached final FDA guidance status in September 2025 specifically for manufacturing and quality operations at medical device companies; other markets and operational areas continue to follow the CSV approach until broader guidance is issued. Part 2 of this series continues with cloud/SaaS technology considerations, AI/ML/LLM topics, FDA enforcement trends, and inspection readiness.
This webinar benefits the following agencies-
Who should attend?
Day 2- From CSV to CSA, Part 2: Cloud, SaaS, AI/ML, and FDA Inspection Readiness
Part 2 of this two-part series turns to the technology and readiness side of the CSA transition. It covers Commercial-Off-the-Shelf (COTS) solutions, cloud services, Software-as-a-Service (SaaS), Platform-as-a-Service (PaaS), and Infrastructure-as-a-Service (IaaS), along with Single-Sign-On (SSO) capability and how to conduct an effective vendor audit.
The session then introduces Artificial Intelligence and Machine Learning concepts, Large Language Models such as ChatGPT, Retrieval-Augmented Generation, and Recursive Language Models, along with FDA’s and industry’s current focus on these technologies.
It closes with a review of current FDA regulatory enforcement trends, the different types of FDA inspections, how to conduct an effective internal audit, and industry best practices for inspection readiness. Attending Part 1 first is recommended for full context but not required, since Part 2 focuses on a distinct set of topics.
This webinar benefits the following agencies-
Who should attend?