In this two-day stage 2 data integrity/governance course, we discuss intermediate GXP data integrity and data governance concepts, with the goal of preparing individuals for success in an ever evolving technology and regulatory landscape. This is an intermediate workshop that includes ~50% lecture and ~50% hands on individual and group problem solving. Participants will be challenged to apply critical thinking in the context of GXP data integrity through discussion and debate, and will be equipped with the experience and insight necessary to operate as a thought leader in the area of data governance within their organization. The workshop will culminate with a final project: the design and presentation of a data governance plan using risk-based strategies to ensure data integrity.
Thought leaders will gain the background necessary to:
apply critical thinking during the process and data mapping
perform assessment of new or existing processes to determine if the level of residual risk acceptable,
develop and execute risk-based strategies for GXP review by exception,
develop and execute risk-based strategies for GXP audit trail review,
optimize the use of data through implementation of FAIR principles within an existing Quality System,
participate in the planning and execution of a data governance strategy in compliance with regulatory expectations, and
seamlessly integrate quality risk management within the data integrity/data governance compliance plans
This course is a continuation of Stage 1, as we practice utilizing the tools that will allow us to achieve our goal: a flexible and risk-based approach towards managing our GXP data processes. Most, if not all, of our data processes are in some form hybrid, as humans interact with the systems in various ways during data entry, transcription, review, and/or lifecycle management. Through practicing and sharing best practices during use of the data/process mapping tool considering steps and system interfaces, in combination with risk-management principles, we can gain confidence that our ultimate management strategies are indeed patient-centric and truly inspection ready!