Quality Management Systems 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.
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.
Register Now
Learning Objectives
Upon completion of this training course, the attendee will be able to:
- Describe the impact of quality and the Quality Unit (QU) on all areas of operation
- Define the roles and responsibilities of the QU
- Describe the foundations of an effective QMS
- Describe the critical role of senior management in QMS
- Explain the concept and basic principles of product knowledge and process understanding
- Explain the basic principles of Quality Risk Management (QRM)
- Describe how internal audits and external inspections can support an effective QMS
- Explain the principles and best practices surrounding data integrity
- Explain the principles of a Quality Culture mindset
Practical activities will include case studies, inspectional observation and warning letter responses, quality culture assessments, and data integrity risk evaluations.