Computer Systems Validation | March 20, 2018 1:00 PM - March 20, 2018 2:30 PM | Automation.com

Computer Systems Validation

Event Summary

DATE:
March 20, 2018
START DATE/TIME:
March 20, 2018 1:00 PM
END DATE/TIME:
March 20, 2018 2:30 PM
TIME ZONE:
EVENT TYPE:
Webinar
HOST:
Training Doyens
PHONE:
+1-720-996-1616
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

Description

OVERVIEW

This will cover the history of Computer Systems Validation in the Pharmaceutical and Medical Device industries. This led to the regulation 21 CFR Part 11, which covers the management of both electronic signatures and electronic records.

Compliance to relevant regulations using Standard Operating Procedures and required documentation will be covered.

The roles of Audits, Quality Assurance, and Risk Management will also be covered.

WHY SHOULD YOU ATTEND

Changes continue to be implemented in many existing computer systems and in many cases computer systems are being replaced or upgraded using new technologies.

Many of these changes require Validation and Validation typically involves almost everyone who uses or supports the systems.

Doing Validation is a “Project” that requires participation of many of those involved in the system. Some of this involves strong management commitment to the accuracy and quality of the products of the systems.

AREAS COVERED

History of Validation Regulations
Some CSV Standards to use
Standard Operating Procedures
Necessary Documentation

LEARNING OBJECTIVES

Understand Computer Systems Validation
Cover The role of Electronic Records
Learn the Compliance to 21 CFR Part 11
The role of Qualification in Validation
Preparation of Standard Operating Procedures
The Documentation needed for Validation

WHO WILL BENEFIT

IT Staff
Computer System Users
Quality Assurance
Regulatory
System Vendors

For more details click on this link:
http://bit.ly/2GvIrBL


You may also refer to this link:
https://www.trainingdoyens.com/product/50169-oos-oot-investigation
https://www.trainingdoyens.com/product/50175-capa-training-webinar

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