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    Computerized Systems Validation

Training "Introduction to Computerized System Validation (CSV) applied to Clinical Research and Pharmacovigilance" 

Program

  • Computerized System Validation's environment
  • Global approach to validation
  • Cycle of validation
  • Process / Procedure support
  • CSV applied to operational systems such as data management, statistics, and pharmacovigilance
  • Main findings identified during audits and inspections

Teaching methods

  • A training that balances presentations and exercises

Attendees' profile

  • Staff involved in Computerized Systems Management, Auditor, Assurance Manager, Operational Managers: Data Manager, Statistician, and Pharmacovigilant

Trainers

  • Mrs. Cindy ARLAUD (Consultant)
  • Mrs. Frédérique ALBOUY-NAVARRO (Doctor of Pharmacy)
  • Mrs. Catherine MERAT (Doctor of Pharmacy)

Practical criteria

  • Place: Paris area
  • Duration: 1 day
  • Schedule: 9h30-18h00
  • Rate: €800 per attendee (taxes not included), including educational fees, documentation, lunch, and coffee breaks

 

 Downloads 

Coming Soon !

  • Training Program
    (pdf French version)
  • Subscription Bulletin
    (pdf French version)

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