Regulatory Compliance Associates’ (RCA) Susan Schniepp, Distinguished Fellow at RCA and Chair of the Board of Directors at the Prenatal Drug Association (PDA) leads this Data Integrity In-Person Training Course in collaboration with the FDA through the Compounding Quality Center of Excellence and the PDA.
This course was also offered on February 25-26, 2025 in Durham, NC.
Course Description
In this two-day course, key concepts to consider when designing processes that collect and utilize data and associated metadata will be discussed. The overall goal is to ensure data is complete, consistent, and accurate through consideration and control of sources of variability stemming from hardware, software, personnel and documentation. Processes that are well designed from the beginning, reduce the risk that a critical decision is made using unreliable data.
This course combines lecture, discussion, small group breakout exercises, and case studies to evaluate the current regulatory expectations and best practices for data integrity, with an overall focus on safety of the patient through good scientific process design principles. This course is targeted for regulators and personnel working in outsourcing facilities (503B) who collect, review, manage or utilize data and/or metadata.
