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Site language : English - Français
Ref : 28936
Event :FDA Compliance and Clinical Trial Computer System Validation

Date :Wednesday February 27th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

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

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

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
Professionals, 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.
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For more information on FDA Compliance and Clinical Trial Computer System Validation, plsase contactr ComplianceOnline

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