Data Integrity In-Person Training Course
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 training 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.
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Learning Objectives
Upon completion of this training course, the attendee will be able to:
- Understand the regulatory expectations for data integrity and current FDA thinking on the topic through the FDA Guidance for Data Integrity to enhance further understanding in establishing a robust data integrity program
- Describe and understand basic requirements for data integrity and the risks associated with poor data integrity processes and improper or poorly trained staff
- Understand critical requirements for a robust data integrity program
- Understand the pros and cons of paper, electronic, and hybrid data integrity programs
- Understand the importance of training and qualification of personnel in managing data integrity