Online Safety Community

Computer Systems Validation

Event Details

Computer Systems Validation

Time: May 3, 2018 from 1pm to 2:30pm
Location: Training Doyens 26468 E Walker Dr
City/Town: Aurora
Website or Map: https://bit.ly/2GWRgEY
Phone: +1-720-996-1616
Event Type: online
Organized By: Training Doyens
Latest Activity: Apr 12

Export to Outlook or iCal (.ics)

Event 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 detail please click on this below link:

https://bit.ly/2G8q7zu

 

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

Comment Wall

Comment

RSVP for Computer Systems Validation to add comments!

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
15 hours ago
Adam Fleaming posted a blog post

Simple but [Important Things] to Remember About FDA Trainings

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of ensuring safety and reliability of the products.This…See More
15 hours ago
Training Doyens posted events
17 hours ago
John Robinson posted events
Friday

Forum

Safety - A Prerequisite 12 Replies

Whether working at home or outside, to observe safety should be our pre-requisite. The employer before anything must be sure of the safety of its employees especially the ones working in mines or any…Continue

Tags: products, safety

Started by Enna Henry. Last reply by Jen McDade 18 hours ago.

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service