Data Integrity - Understand the Data Lifecycle
Data Integrity is one of the most urgent topics in the GxP regulated area. Regulators have increasingly emphasized the importance of Data Integrity.
Good documentation, record keeping, and data integrity are an essential part of the Pharmaceutical Quality System (PQS) and key to operate in compliance with GMP requirements and also, even more important, in protecting the quality of the product and the safety of the patient.
Companies must maintain and ensure the accuracy and consistency of data and records over their entire lifecycle. A lack of Data Integrity leads to serious regulatory consequences.
The course will be conducted by Dr. Lothar Hartmann, Managing Director of Phact GmbH, who will share his longstanding expertise in implementing Pharmaceutical Quality Systems. During practical exercises you can deepen your knowledge and exchange your experience with other course participants.
If you are interested to register for the workshop, please contact us at email@example.com.
Please indicate whether you are interested to register for an individual use or for a team.
- Practical aspects of data integrity, e.g. lifecycle, validation, migration, indicent management, cloud computing
- Where data are generated
- Data security
- Data governance
- Risk management in data integrity
- Audit trail
This workshop addresses experts from Quality and other departments that are involved in dealing with data.
half day (4 hours)
The course material will be provided to the participants at the beginning of the training.
CHF 450,00 excl. VAT (CHF 486,45 incl. VAT)
Each participant will receive a certificate of participation at the end of the training.