HEALTHCARE TRAINING 2021 - Computer System Validation (CSV) for FDA-Regulated Computers

Website https://www.compliance4alllearning.com/webinar/computer-system-validation-(csv)-for-fda-regulated-co | Edit Freely

Category HEALTHCARE TRAINING 2021

Deadline: July 08, 2021 | Date: July 08, 2021

Venue/Country: Online event, U.S.A

Updated: 2021-05-31 19:33:09 (GMT+9)

Call For Papers - CFP

The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

This includes development of a company philosophy and approach, and incorporating it into an overall computer system validation program and plans for individual systems that are regulated by FDA.

FDA's guidelines for computerized systems were enacted in 1983, and very little has changed, other than technology, since that time, as it relates to validation. The premise for compliance is demonstrating clearly and completely that a computer system does what it purports to do. This means developing a very detailed set of unique and testable functional requirements, and creating a set of test scripts that will prove each requirement is met.

This webinar will describe the approach to determining the level and robustness of testing required, based on a thorough risk assessment of the system, which includes the likelihood, severity, and detectability of potential failures of the system to work as expected, and the mitigation to be applied, should the system fail. Along with system categorization, in accordance with GAMP 5 principles, and an evaluation of the complexity and application of the software, the attendee will understand how to develop the rationale they will include in the validation plan for the level of testing executed.