Understand and apply ALCOA+ data integrity principles to DSP processes, and develop the ability to investigate and resolve data integrity deviations effectively.
Scientific background, initial experience in bioindustries, chemistry, pharmacy.
Course modules
about 2 hours
Data integrity for DSP in cGMPs
This activity defines the concepts of data, data integrity, and data lifecycle in the context of DSP. It presents the key challenges and fundamental principles to be followed to ensure the reliability and traceability of information throughout the process.
This activity presents practical use cases to identify and resolve situations where data integrity is compromised. It trains to adopt the appropriate reflexes to preserve the reliability of records throughout the DSP process.
This activity presents the impacts of digitalization on data integrity in the DSP environment. It addresses the behaviors to adopt in order to ensure that digital records comply with cGMP requirements.
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