Mastering Challenges of Data Integrity and Computer System Validation - Training / Workshop von PDA Europe gGmbH

Inhalte

Data Integrity is currently a hot topic in the pharmaceutical industry and in the focus of health authority inspections.

A properly validated computer system allows to establish and maintain over time the data integrity: once the regulatory requirements are met through a consistent and rigorous validation process, this implies that the required controls are in place.

This 2-day training course provides practical guidance to understand the basics of data integrity and computer system validation and offers real world learning examples of integrated approaches. A mixture of lectures and interactive sessions provides a maximum of learning success.

On the first day the focus is on regulatory foundation of data integrity, ALCOA(+) principle, data governance, modelling of data/process flows, and hybrid systems. The second day consists of workshops around risk evaluation and presentation/discussions about general principles of computer system validation and audit trail reviews.

Lernziele

Learning Objectives
  • Acquire basics about Data Integrity and Computer System Validation
  • Apply concepts of data integrity on computer system validation
  • Gain experience through real world examples
  • Obtain knowledge to deal with the audit trail review challenge
  • Understand the ideas behind ALCOA
  • Perform computer system validation by your own

Zielgruppen

Who Should Attend
  • Managers responsible for IT systems in pharma and supplier companies
  • Validation Managers
  • Laboratory Supervisors
  • Production Supervisors
  • QA Managers
  • Everybody, who is involved in the topics of Data Integrity and Computer System Validation

SG-Seminar-Nr.: 5176106

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