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

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.

• 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

• 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