In this two-day stage 2 thought leader course, we discuss intermediate and advanced 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/advanced 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 mapping and 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,
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