Computer System Validation (CSV) for FDA-Regulated Computers
OVERVIEW FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with FDA system validation rules . You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on the System Development Life Cycle (SDLC) Methodology . The webinar will leave you with the information needed for planning, executing and documenting a computer system validation effort that meets FDA compliance standards. You will learn about the computer system validation requirements and what must be done to ensure the system remains in a validated state. In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System ...