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.
