Implementing 21 CFR Part 11 - What is Computer Systems Validation and How to Implement It - by Compliance Global Inc

New Hyde Park, NY, April 18, 2015 --(PR.com)-- Overview

The webinar will cover the Computer Systems Validation Regulations and then cover how a company complies with those regulations when they implement a computer system.

Why Should You Attend

The requirements of FDA CFR Part 11 apply to the implementation and use of computer systems that are used to manage information that is to be submitted to the Agency (FDA).

By validating the systems you are assuring that they are functioning properly and are not posing a risk to patients or others. When a submission is made to FDA it is likely that the FDA will do an inspection and they will review the process validation documentation and procedures.

Areas Covered in the Session

This curse will cover the procedures that are to be followed and discuss all of the documentation that is to be prepared to meet the requirements of this regulation. Typically a System Development Life Cycle (SDLC) will be used to identify the Tasks to be performed, Those responsible for the tasks including those that are Responsible for the contents, the Deliverables that are to be produced that establish the Documented Evidence that the Computer System is working as intended.

Learning Objectives

Be able to develop a Validation Plan
Contribute to the development of Specifications
Follow Programming Standards, if programming
Build and execute Test cases
Install and operate the Systems
Develop Ussr documentation
Contribute to Change Control

Who Will Benefit

IT Staff implementing and supporting these computer systems
Users of the computer systems
Quality Assurance Staff faced with auditing computer systems
Vendors of these “Regulated “computer systems

About Compliance Global Inc:

Compliance Global Inc; is a training (webinar) organization based in New Hyde Park, New York, providing world-class compliance trainings and online webinars by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare, BFSI, Life Science & HR streams for improving the knowledge base of the customers. Our trainings are contemporary, simple and cost-effective with easy access and great delivery experience. Compliance Global is a multifaceted entity, an absolute knowledge repository.

Our varied industry expertise ranges across Life Science (Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance), Healthcare, HR Compliance, BFSI, Food & Dietary Supplements, Insurance, Accounting & Taxation and other Cross Industry streams.