This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards. You will learn about 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.
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, and GCP) related products be validated and maintained in accordance with specific 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.
WHY SHOULD YOU ATTEND
This FDA Compliance training will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
WHO WILL BENEFIT
All FDA-regulated industries:
For more detail please click on this below link:
Toll Free: +1-888-300-8494