As our regulatory paradigm continues to shift, QC/QA staff members must be able to effectively execute the establishments QC/QA program. With these job responsibilities, there is also a need to develop and manage a QC/QA training program that ensures a deep understanding of the FDAs requirements for the execution of our quality systems. The FDA expects the QC/QA unit to have the appropriate education and training in quality principles to enable them to perform their duties. These duties are not just about the review of checking the boxes, but also ensuring that the QC/QA reviews for regulatory compliance are well planned and demonstrate alignment of the processes to operational regulatory compliance. This workshop is intended to review some of the principles associated with gaining a strong foundation and deep understanding of quality principles for new incumbent QC/QA staff as well as continued development of the seasoned QC/QA employee.