Developing a Strategic Approach to FDA Compliance for Computer System Validation – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on Oct 10, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Carolyn Troiano

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You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV).

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 forms 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 FDA Compliance training, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state. This will provide you with a level of certainty that you will be able to respond to FDA questions and provide the documentation necessary to defend your approach and body of work.

Learning Objectives:

  • Learn about industry best practices related to compliance and computer system validation
  • Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
  • Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • ….. and more

Session Highlights:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • ….. and more

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