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Langue du site : Français - English
Réf : 28936
Evènement :FDA Compliance and Clinical Trial Computer System Validation

Date :Mercredi 27 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.

Objectives

Upon completing this course participants should:

  • Understand FDA requirements for clinical trial Computer System Validation (CSV)
  • Understand the System Development Life Cycle (SDLC) approach to validation
  • Utilize GAMP 5 system classification and risk methodologies for categorizing systems and developing a validation pathway
  • Understand how to build a complete validation strategy and program for clinical trial systems
  • Know how to manage the validation process and create FDA-compliant documentation
  • Know how to monitor a clinical trial system that is in production, governing the data and system through retirement
  • Understand the roles and responsibilities required to validate a clinical trial system
  • Know how to measure cost vs. compliance risk for a clinical trial system
  • Understand good project management principles, incorporating business process re-engineering and organizational change management into the process
  • Know the policies and procedures that must be developed and maintained to support the clinical trial system in operation
  • Understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system
  • Know about FDA trends in oversight and audit of clinical trial systems and how to keep abreast of these
 

Program

This course includes the following key areas of learning:

  • FDA GxPs
  • Computer System Validation (CSV) Methodology
  • System Development Life Cycle (SDLC) Framework
  • Risk Management
  • GAMP 5
  • Compliance Strategy
  • Cost vs. Compliance
  • Industry Best Practices
  • Policies and Procedures
  • Training
  • Leveraging Vendors

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

FDA Compliance and Clinical Trial Computer System Validation Management
clinical trial computer system validation, fda compliance training, gcp training, gxp compliance, system development life cycle, gamp, risk management
Professionnels, 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 This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, Validation and compliance.
10 -- --
English

Divers

Pour plus d'informations sur FDA Compliance and Clinical Trial Computer System Validation, veuillez contacter ComplianceOnline

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