Although Data Integrity has been one of the basic GMP requirements for decades it became the regulators’ focus of attention over the last few years. In the course of inspections of the U.S American FDA and European competent authorities, a lot of deviations and failures on that topic were detected. Current FDA Warning Letters and European Non-Compliance reports reflect the situation and show the weak points of data management in pharmaceutical companies. Meanwhile, major international authorities like FDA, MHRA, WHO and PIC/S have developed new Guidelines and Guidances on Data Integrity and Data Governance to explain their expectations to the industry.
In the GMP Certification Programme "Data Integrity Manager", participants obtain a comprehensive knowledge of the basic principles of Data Integrity and Data Governance. Participants will understand the data lifecycle and how the regulatory expectations can be implemented into the companies’ Quality System