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Langue du site : Français - English
Réf : 29001
Evènement :Live Webinar on Functional System Requirements for Computer Systems Regulated by FDA

Date :Mercredi 13 Mars 2019

Lieu :Training Doyens 26468 E Walker Dr
80016-6104 Aurora, Colorado, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

 

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.
  • Industry best practices related to CSV and the SDLC methodology, as well as for delivering solid requirements.
  • Common findings of FDA related to CSV during computer system inspection and audit that can be avoided by following best practices to develop solid requirements as part of the effort.

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.
  • Training and organizational change management best practices to support CSV and development of detailed and thorough requirements for testing.
  • Preparing your computer system documentation for an FDA inspection.
  • Q&A

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.
  • This course will describe the best practices for developing detailed and thorough FDA system validation requirements, including roles and responsibilities, and the policies and procedures that should be followed to ensure compliance.
  • We will provide specific guidance on industry best practices for delivering solid requirements that will meet FDA compliance.

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
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers
  • Consultants working in the life sciences industry who are involved in the validation of computer systems.

 

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

 

 


Lieu

Plan et itinéraire
Adresse de la conférence :
Training Doyens 26468 E Walker Dr
80016-6104 Aurora
Colorado, États-Unis
Tél : +1-720-996-1616
Plan et itinéraire

Renseignements

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Précisions

Live Webinar on Functional System Requirements for Computer Systems Regulated by FDA Pharmacie
fda system validation, gxp validation, fda compliance training, fda regulatory training
Professionnels
20 1 --
English

Divers

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