Implementing a Robust Data Integrity Program- 2019

Overview: Attendees will be presented with an overview of the audit trails within an application and the content of each one, Also Attendees will be presented with a list of records to identify if they are GMP records. Why should you Attend: The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines. Areas Covered in the Session: File format Storage media Encryption User management (access control) Review of the data life cycle Handling of raw data