Training Doyens

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 specific rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on System Development Life Cycle (SDLC) Methodologies. The 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. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodologies when validating computer systems subject to FDA regulato...

OVERVIEW This webinar 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. WHY SHOULD YOU ATTEND An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated.  In this webinar, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them ...