Events

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.

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 Quality Management Systems In-Person Training Course in collaboration with the FDA through the Compounding Quality Center of Excellence and the PDA.

Course Description

Learn the fundamentals of establishing an effective Quality Management System (QMS) and building a culture of quality within a facility. This training course includes information about the comprehensive QMS approach to quality, the critical role of senior leadership, and building a quality culture mindset throughout the organization. The course will also explore the concepts of knowledge management, quality risk management, and data integrity. Practical activities will include the use of case studies, responding to inspectional observations and warning letters, conducting quality culture assessments, and evaluating data integrity risks.