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In-Depth Computer System Testing of Computer Systems Regulated by FDA

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Deadline: April 20, 2017 | Date: April 20, 2017

Venue/Country: Online

Updated: 2017-03-09 20:01:34 (GMT+9)

Call For Papers - CFP

We will discuss the importance of applying industry best practices when testing IT system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Testing is a key component of Validation, as part of the System Development Life Cycle (SDLC).

Why Should You Attend

This course will describe the best practices for testing, including “who" should be responsible for tasks, "how" the testing should be accomplished, and “what” specific criteria will be used to define acceptance. FDA guidelines are very specific in terms of how this is to be done.

Areas Covered in this Webinar

This webinar will cover the following key areas:

GxP systems

Computer System Validation (CSV)

System Development Life Cycle (SDLC)

Testing in an FDA-regulated environment

Test Planning, Execution, Discrepancy Resolution and Documentation

Test Summary Report

Unit and Integration Testing

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ; also User Acceptance Testing, or UAT)

Test Scenarios, Test Cases and Test Scripts

Positive and Negative Test Scenarios

Stress and Boundary Testing

Training (Users, Support)

Learning Objectives

Upon completion of this session, attendees will have an understanding of computer system testing concepts and how these efforts are to be adequately documented to meet FDA requirements. They will understand the steps required for documenting the test planning, execution results and summary reporting. The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for testing.

Who Will Benefit

Within FDA-regulated companies, people in the following roles will benefit from this presentation:

- Computer System Validation Specialists

- Information Technology Professionals

- Automation Analysts and Managers

- QC/QA Analysts and Managers

- Laboratory Analysts and Managers

- Manufacturing Analysts and Supervisors

- Supply Chain Managers and Analysts

- Compliance and Audit Managers

- GMP Training Specialists

- Business Stakeholders/Subject Matter Experts

- Business System/Application Testers

Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for computer system validation.

Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.

For More Info, Please Click below URL:

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.