Computerised Systems Validation

Validation makes good business sense: PharmaTraining Services offer training in computerised systems validation as a regulatory requirement for the pharmaceutical industry.

Do you want less downtime?
Do you want to lower your maintenance costs?
Are your systems “fit for intended use”?

Computerised Systems Validation

The validation of computerised systems is not only a regulatory requirement in the pharmaceutical industry it also makes good business sense. Robust systems are easier to support and maintain, resulting in less downtime and lower maintenance costs.

Validation of Computerised Systems
12 & 13 May 2009
Radisson SAS Royal Hotel, Dublin Ireland

This course on validation and GxP compliance of computerised systems in the pharmaceutical industry is based on GAMP5.0 and the latest regulatory and industry developments.

The course is highly practical and includes a mix of theoretical introductions and workshops covering the main activities to be executed during the life cycle of a system.

Upon completion of the course participants will have a complete understanding of the terminology used and the validation activities that need to be performed throughout the life cycle of a Configurable Off the Shelf System (COTS) and

  • Understand the GAMP 5 principles
  • Oversee all required validation activities (SLC)
  • To appoint the relevant Standard Operating Procedures (SOPs)
  • Able to execute the validation of a “simple” system
  • To participate when validating a “complex” system
  • Discuss validation issues with validation and Quality experts.

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