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Live Webinar on Functional System Requirements for Computer Systems Regulated by FDA

Event Details

Live Webinar on Functional System Requirements for Computer Systems Regulated by FDA

Time: March 13, 2019 from 1pm to 2:30pm
Location: Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016
Street: Training Doyens 26468 E Walker Dr,Aurora, Colorado
City/Town: Aurora
Website or Map: https://bit.ly/2WIaF56
Phone: +1-720-996-1616
Event Type: online
Organized By: Training Doyens
Latest Activity: Feb 5

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Event Description

OVERVIEW

This webinar will take you through the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV), focusing on the definition, testing, and documentation of functional and other requirements to ensure the system meets FDA compliance.

This FDA compliance training will help you understand how the definition of functional and other system requirements fit into the System Development Life Cycle (SDLC) approach to Computer System Validation (CSV). Getting the requirements right, and ensuring they are comprehensive, is one of the most challenging components of the process.

WHY SHOULD YOU ATTEND

You should attend this webinar to learn about:

  • Computer System Validation (CSV) approach.
  • Using the System Development Life Cycle (SDLC) methodology to support CSV efforts.
  • CSV and SDLC deliverables that must be documented properly to comply with FDA requirements.
  • A deeper dive into the Functional Requirements Specification (FRS) deliverable, a key document to support the CSV effort.
  • Policies, procedures, training, and organizational change management that are all key aspects of a successful CSV effort and developing detailed and thorough requirements.

AREAS COVERED

  • Requirements for Computer System Validation (CSV) in compliance with FDA.
  • Applying a strategic approach to CSV for FDA compliance.
  • Using the System Development Life Cycle (SDLC) methodology to support CSV.
  • CSV strategic planning, execution, and documentation.
  • Detailed analysis of the Functional Requirements Specification (FRS), a key deliverable for the CSV effort.
  • Policies and procedures to support the CSV effort and your requirements.

LEARNING OBJECTIVES

  • We will provide an overview of FDA’s guidelines as they pertain to computer system validation of GxP systems used in manufacturing, marketing, distribution and other operational activities engaged by companies in FDA-regulated industries.
  • We will describe the System Development Life Cycle (SDLC) methodology and how to apply it to Computer System Validation (CSV) work.
  • We will review the SDLC deliverables key to a successful CSV effort.
  • We will take a deeper dive into the Functional Requirements Specification (FRS) process and documentation to support a successful CSV effort.

WHO WILL BENEFIT

This webinar will provide valuable assistance to all personnel in:

  • Data “Owners”
  • Data “Stewards”
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Compliance and Audit Managers
  • Laboratory Managers
  • Automation Analysts

 

For more detail please click on this below link:

 https://bit.ly/2Bn14r8

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

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