Data integrity is a prime focus of regulatory agencies who have recently issued a number of guidance documents on the topic. This highly interactive course will explore the role of data integrity throughout the drug development lifecycle and will review key highlights of current international regulation and guidance from US FDA, MHRA, PIC/S and WHO.
This training course will help you on the latest in international regulatory requirements, guidances and best practices, present a model for improvement, and allow attendees to interactively address and brainstorm customized solutions to optimize meeting those requirements on a consistent basis. During this training course, a model for data integrity improvement will be presented and customized, and attendees will leave with a personalized action plan for implementation back at their facilities. Using case studies, small group exercises, and discussion, attendees will identify the ways that human factors and corporate culture impact data integrity.