Time: July 10, 2018 from 3pm to 4:30pm
Location: Training Doyens 26468 E Walker Dr
Street: 26468 E Walker Dr, Aurora, Colorado 80016
Website or Map: https://goo.gl/uZe1Sy
Event Type: online
Organized By: Training Doyens
Latest Activity: Jun 7
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 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.
WHO WILL BENEFIT
All FDA-regulated industries:
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