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SUNNIKAN Consulting
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Agenda 2010
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    Quality, Process and Risks Management
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    Computerized Systems Validation

Training "Quality, Process, and Risk Management in Clinical Research, Regulatory Affairs and Pharmacovigilance"

  • Better position the role of the Quality Manager and enable him/her to define and set a Quality Approach
  • Introduce the Quality tools

Program

  • Quality management: concepts and requirements, quality system elements
  • Processes control
  • Documentation control
  • Introduction to risk management
  • Introduction to Computerized System Validation

The monitored training provides an overview, and prepares attendees with an action plan and tools to initiate a Quality Manual

Teaching methods

  • A training that balances presentations, simulation exercises, and experiences sharing

Attendees' profile

Anyone who wishes to gain or consolidate their conceptual and practical knowledge of quality and process management:

  • Manager, Quality Manager, Quality Correspondent, Methods Manager

Trainers

  • Mr. Georges MARTIN (Engineer, Doctor of Medecine)
  • Mrs. Frédérique ALBOUY-NAVARRO (Doctor of Pharmacy)
  • Mrs. Mélanie GENTRIC-GUERIN (Doctor of Pharmacy)

Practical criteria

  • Place: Paris area
  • Duration: 2 days
  • Schedule: 9h30-18h00
  • Rate: €1,600 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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