Computerized systems engineering, quality, compliance

Computerized systems validation GAMP5 approach (2 days)

Courses objectives

  • Understand and assimilate the validation guidelines applied to computerized and automated systems according to the validation methodology GAMP5 and new Data Integrity requirements
  • Assimilate and apply GAMP5 concepts, ASTM E2500 approach and new Data Integrity main concepts
  • Assimilate and apply the 21CFR part 11 and new Annex 11 “risk analysis” approach.
  • Assimilate a “modular” approach to Validation in order to be able to define the activities and effort required to validate each automated and computerized system
  • Assimilate the writing of the protocols and test sheets

Training methods

  • Based on GAMP5 methodology and Data Integrity guidances
  • Case studies
  • Working groups
  • Presentation

Audience

  • Everyone involved in the computerized and automated systems validation process (ERP, GPAO, LIMS,SCSE, WMS, SCC, MES, automats…) : IT and automated (technical and functional) project managers, users project managers, validation managers, representative of the quality assurance department.

Dates and costs

April 11th and 12th / October 3th and 4th – PARIS
April 25th and 26th / October 17th and 18th – LYON
Cost : 1150€ excl. VAT, breaks and lunch included.